AccessGUDID - DEVICE: Wassenburg® Transport Cart TC-6 (G434TC61)

GUDID

Device Identifier (DI) Information

Brand Name: Wassenburg® Transport Cart TC-6
Version or Model: TC-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wassenburg Medical, Inc.

Primary DI Number: G434TC61
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118762097 *Terms of Use

Device Description: The Transport Cart TC-6 is designed to protect flexible endoscopes from airborne contaminants and potential damage during transport between the procedure room and the reprocessing room.

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):	Yes
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?
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope

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: 7de54cc6-9159-4ecf-b4e4-6f3b75aab8e3
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023