AccessGUDID - DEVICE: SilvaKollagen Gel (01714196500150)

GUDID

Device Identifier (DI) Information

Brand Name: SilvaKollagen Gel
Version or Model: 00500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00500
Company Name: DERMARITE INDUSTRIES LLC

Primary DI Number: 01714196500150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 883925562 *Terms of Use

Device Description: Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial cuts, lacerations, abrasions, irritations of the skin. RX for partial and full thickness wounds. Store at controlled room temperature. Silver oxide controls the growth of microbes that are absorbed into the wound gel. https://dermarite.com/product/silvakollagen-gel/

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):	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?
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. 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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 34a3a706-4dda-41ff-88aa-1ca0743612b7
Public Version Date: October 12, 2023
Public Version Number: 1
DI Record Publish Date: October 04, 2023