AccessGUDID - DEVICE: View Guard Transparent Film Dressing Roll (00616784363912)

GUDID

Device Identifier (DI) Information

Brand Name: View Guard Transparent Film Dressing Roll
Version or Model: 3639
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784363912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: View Guard Transparent Film Dressing Roll; Semi-Permeable; Non-Sterile, 2"x11yds

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?
58300	Synthetic polymer semi-permeable film dressing, adhesive, non-sterile	A non-sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to skin typically intended to fix a primary dressing or a medical device (e.g. drainage tube), or to provide protection from fluids. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: 213097d9-3463-4093-9ad7-43e2fd283981
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2021