AccessGUDID - DEVICE: Bioguard Burn Dressing - Ready-Cut Gauze (00809958088906)

GUDID

Device Identifier (DI) Information

Brand Name: Bioguard Burn Dressing - Ready-Cut Gauze
Version or Model: 97118
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 97118
Company Name: Derma Sciences Canada Inc

Primary DI Number: 00809958088906
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: Bioguard Burn Dressing - Ready-Cut Gauze, 100 Ply - Mesh Gauze 18 in x 18 in (45.7 cm x 45.7 cm)

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):	Yes
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?
62184	Synthetic nanofiber barrier dressing	A sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NYS	Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 958cbabf-f7ee-4359-b0f1-26320565125e
Public Version Date: June 25, 2024
Public Version Number: 6
DI Record Publish Date: January 16, 2017