AccessGUDID - DEVICE: Zutron Medical (00817658023400)

GUDID

Device Identifier (DI) Information

Brand Name: Zutron Medical
Version or Model: Endoscopy Procedure Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZUTR40125
Company Name: ZUTRON MEDICAL, L.L.C.

Primary DI Number: 00817658023400
Issuing Agency: GS1
Commercial Distribution End Date: April 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962532441 *Terms of Use

Device Description: Endoscopy Procedure Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Transport Tote, Channel Cleaning Brush, Vent Bag

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
61950	Endoscopy preparation kit	A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWU	Endoscope Introducer Kit

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: dd41f23b-d231-4671-8ca8-859536b03010
Public Version Date: April 30, 2024
Public Version Number: 2
DI Record Publish Date: July 28, 2023