AccessGUDID - DEVICE: Fisherbrand (00613647002360)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: KZ401-NO.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22363100
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647002360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: TAN 1X5 LATX FREE 30/CS

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?
58964	Non-adhesive device retention bandage	A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	BANDAGE, ELASTIC

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: 8eae3220-a37a-4c6f-8c26-1e015e951519
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022