AccessGUDID - DEVICE: DermaTex (14052199536078)

GUDID

Device Identifier (DI) Information

Brand Name: DermaTex
Version or Model: Silver Moisture Wicking Fabric Silver
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15700002
Company Name: ADVANCED MEDICAL SOLUTIONS LIMITED

Primary DI Number: 14052199536078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 770434090 *Terms of Use

Device Description: Moisture Wicking Fabric with Silver Dressing.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
62291	Antimicrobial skin friction/moisture control fabric, single-patient reusable	A non-sterile absorbent textile material intended to be applied in skin folds or where skin-to-skin contact occurs (e.g., armpits, under the breasts, stomach, groin, and between fingers or toes) to prevent or reduce skin-to-skin friction, moisture, and irritation/inflammation; it is not intended to be used on open wounds. It is made of natural and/or synthetic materials and contains an antimicrobial agent [e.g., silver (Ag)]. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	Fiber, Medical, Absorbent

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: a84763ef-fd97-41e7-9e39-a243fe8d4d39
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022