AccessGUDID - DEVICE: NA (04055207009826)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 838341
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8383.41
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207009826
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: GRASPING FORCEPS Ø 5MM WL 310MM diameter 5 mm, working length 310 mm, with grooved plates, with spring handle and cleaning channel

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":	No
For Single-Use:	No
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?
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 310 Millimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 2eb8e848-bdbf-41b4-8939-0f4270e507ad
Public Version Date: May 23, 2023
Public Version Number: 2
DI Record Publish Date: August 09, 2022