AccessGUDID - DEVICE: K.T.Surgico (KTS1018012)

GUDID

Device Identifier (DI) Information

Brand Name: K.T.Surgico
Version or Model: 2023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KTS1018012
Company Name: K.T.SURGICO

Primary DI Number: KTS1018012
Issuing Agency: HIBCC
Commercial Distribution End Date: November 30, 2031
Device Count: 1200
Labeler D-U-N-S® Number*: 645493024 *Terms of Use

Device Description: Adson Tissue (1x2) 4.75"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62479	Surgical soft-tissue manipulation forceps, tweezers-like, single-use	A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	Forceps, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d66af4d0-6622-4d08-93c4-dd159f1e040d
Public Version Date: February 28, 2024
Public Version Number: 1
DI Record Publish Date: February 20, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
MASTER05	1200	TMS1635712	2023-08-29	Not in Commercial Distribution	Master Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: TMS1635712 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +6302795000
Email: uahmed@tmsmed.net

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