Home GUDID 00614464103551
"Gel-E-Roll, 4"" x 48"", 1roll/box"
Primary DI 00614464103551
Brand "Gel-E-Roll, 4"" x 48"", 1roll/box"
Company Silipos Holding LLC
Model 10355
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 Code Name FMP Protector, Skin Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMP Protector, Skin Pressure General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00614464103551 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00614464103551 00614464103551 614464103551 0614464103551
GMDN Terms# Term, Definition table Term Definition Scar management dressing, single-use, non-sterile A 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.
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 DI Brand Model Catalog Published 00614464141157 Post Operative Carpal Sleeve, Small, Left 14115 2022-08-05 00614464141256 Post Operative Carpal Sleeve, Small Right 14125 2022-08-05 00614464141355 Post Operative Carpal Sleeve, Large, Left 14135 2022-08-05 00614464141454 Post Operative Carpal Sleeve, Large, Right 14145 2022-08-05 00614464141652 Carpal Sleeve with 2 Thumb Holes 14165 2022-08-05 00614464142055 Carpal Pads With Pres. Sens. 14205 2022-08-05 00614464341656 Carpal Sleeve with 2 Thumb Holes - Bulk 34165 2022-08-05 00614464928956 Foam Toe Separator (Sheet of 12), Small, 1sheet/bag 92895 2022-08-05 00614464928963 Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag 92896 2022-08-05 00614464928970 Foam Toe Separator (Sheet of 12), Large, 1sheet/bag 92897 2022-08-05 00614464928987 Foam Toe Separator (Sheet of 12), X-Large, 1sheet/bag 92898 2022-08-05 00614464928994 """Deluxe Suede Hammer Toe Crest, Small, Left, 3pcs/bag """ 92899 2022-08-05 00614464929007 """Deluxe Suede Hammer Toe Crest, Small, Right, 3pcs/bag """ 92900 2022-08-05 00614464929014 """Deluxe Suede Hammer Toe Crest, Medium, Left, 3pcs/bag """ 92901 2022-08-05 00614464929021 """Deluxe Suede Hammer Toe Crest, Medium, Right, 3pcs/bag """ 92902 2022-08-05 00614464929038 """Deluxe Suede Hammer Toe Crest, Large, Left, 3pcs/bag """ 92903 2022-08-05 00614464929045 """Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag """ 92904 2022-08-05 00614464929052 """Felt Hammer Toe Crest, Small, Left, 3pcs/bag """ 92905 2022-08-05 00614464929069 """Felt Hammer Toe Crest, Small, Right, 3pcs/bag """ 92906 2022-08-05 00614464929076 """Felt Hammer Toe Crest, Medium, Left, 3pcs/bag """ 92907 2022-08-05
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