AccessGUDID - DEVICE: GEMCORE360 (10610888000329)

GUDID

Device Identifier (DI) Information

Brand Name: GEMCORE360
Version or Model: PHMB Foam Antimicrobial Non-Border, Non-Adhesive
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AM-WC-PHMBFNB44
Company Name: ADVANCED MEDICAL SOLUTIONS LIMITED

Primary DI Number: 10610888000329
Issuing Agency: GS1
Commercial Distribution End Date: April 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 770434090 *Terms of Use

Device Description: PHMB Foam Non-Adhesive (Gamma)

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181197	000

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: e79b2661-9a28-4d45-a771-466df286f049
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: December 07, 2022