RevivaSil Gel Pad Kit

Primary DI
00373352540013
Brand
RevivaSil Gel Pad Kit
Company
Trifluent Pharma, LLC
Model
01
Device description
Kit. Including four scar management dressings, reusable.
Published
2024-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10373352540010PackageGS14In Commercial Distribution
00373352540013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037335254001010373352540010
00373352540013003733525400133733525400130373352540013

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, reusableA non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117167281
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true