AccessGUDID - DEVICE: Protect U Guard Alginate Sterile Dressing (B086191121)

GUDID

Device Identifier (DI) Information

Brand Name: Protect U Guard Alginate Sterile Dressing
Version or Model: P19112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTECT U GUARD, LLC

Primary DI Number: B086191121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 080070945 *Terms of Use

Device Description: Protect U Guard Alginate Sterile Dressing 2x30cm

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):	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?
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

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: 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
Width: 2 Centimeter
Length: 30 Centimeter

Device Record Status

Public Device Record Key: 8af16fd0-4f2a-438c-af15-e7045e0ced9f
Public Version Date: August 31, 2020
Public Version Number: 1
DI Record Publish Date: August 21, 2020