AccessGUDID - DEVICE: SILVEX (00020424321949)

GUDID

Device Identifier (DI) Information

Brand Name: SILVEX
Version or Model: 03COM21094; 03HBC21094NEW; 03HBC21094NEWWAG; 03HBC21094NEWWM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424321949
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: Silvex Wound Gel 0.5 oz Wound Care, All Purpose - (1) Silvex First Aid Gel 0.5 oz (14 g)

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:	No
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?
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140483	000

Device Exempt from Premarket Submission: No 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
Weight: 14 Gram

Device Record Status

Public Device Record Key: 6736a148-be36-4a96-a7bb-45f04b04caf7
Public Version Date: January 29, 2024
Public Version Number: 2
DI Record Publish Date: January 05, 2024