FDA.reportPublic FDA data

"Gel-Care Advanced Gel Sheet, 5""x6"", 10/pkg"

Primary DI
00614464006111
Brand
"Gel-Care Advanced Gel Sheet, 5""x6"", 10/pkg"
Company
Silipos Holding LLC
Model
611
Published
2022-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614464006111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464006111006144640061116144640061110614464006111

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, single-use, non-sterileA non-sterile covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel, polyurethane) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056112948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614464141157Post Operative Carpal Sleeve, Small, Left141152022-08-05
00614464141256Post Operative Carpal Sleeve, Small Right141252022-08-05
00614464141355Post Operative Carpal Sleeve, Large, Left141352022-08-05
00614464141454Post Operative Carpal Sleeve, Large, Right141452022-08-05
00614464141652Carpal Sleeve with 2 Thumb Holes141652022-08-05
00614464142055Carpal Pads With Pres. Sens.142052022-08-05
00614464341656Carpal Sleeve with 2 Thumb Holes - Bulk341652022-08-05
00614464928956Foam Toe Separator (Sheet of 12), Small, 1sheet/bag928952022-08-05
00614464928963Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag928962022-08-05
00614464928970Foam Toe Separator (Sheet of 12), Large, 1sheet/bag928972022-08-05
00614464928987Foam Toe Separator (Sheet of 12), X-Large, 1sheet/bag928982022-08-05
00614464928994"""Deluxe Suede Hammer Toe Crest, Small, Left, 3pcs/bag """928992022-08-05
00614464929007"""Deluxe Suede Hammer Toe Crest, Small, Right, 3pcs/bag """929002022-08-05
00614464929014"""Deluxe Suede Hammer Toe Crest, Medium, Left, 3pcs/bag """929012022-08-05
00614464929021"""Deluxe Suede Hammer Toe Crest, Medium, Right, 3pcs/bag """929022022-08-05
00614464929038"""Deluxe Suede Hammer Toe Crest, Large, Left, 3pcs/bag """929032022-08-05
00614464929045"""Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag """929042022-08-05
00614464929052"""Felt Hammer Toe Crest, Small, Left, 3pcs/bag """929052022-08-05
00614464929069"""Felt Hammer Toe Crest, Small, Right, 3pcs/bag """929062022-08-05
00614464929076"""Felt Hammer Toe Crest, Medium, Left, 3pcs/bag """929072022-08-05

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