AccessGUDID - DEVICE: Tissu-Trans (00893398002332)

GUDID

Device Identifier (DI) Information

Brand Name: Tissu-Trans
Version or Model: Tissu-Trans Special Tubing Adaptor
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3-TT-Adaptor
Company Name: SHIPPERT MEDICAL TECHNOLOGIES, INC

Primary DI Number: 00893398002332
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 051437143 *Terms of Use

Device Description: Adaptor to fit the "L" connector to allow attachment of customer supplied harvest tubing

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUU	System, Suction, Lipoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102117	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: c735f3a7-8fcd-4bae-a176-cf36887a9cbe
Public Version Date: May 08, 2023
Public Version Number: 9
DI Record Publish Date: August 12, 2016