CICA-CARE 15CM X 12CM 66250706, 66250707

GUDID 05000223441814

Silicone Gel Sheet. Treatment for red and raised, old and new scars

SMITH & NEPHEW MEDICAL LIMITED

Scar management dressing, reusable
Primary Device ID05000223441814
NIH Device Record Keyae6b2f41-4bf0-4308-b4a0-2e18162041c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCICA-CARE 15CM X 12CM
Version Model Number66250706, 66250707
Catalog Number66250706, 66250707
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105000223441579 [Primary]
GS105000223441654 [Package]
Contains: 05000223441579
Package: Carton 66250707 [10 Units]
In Commercial Distribution
GS105000223441814 [Package]
Contains: 05000223441579
Package: Carton 66250706 [1 Units]
In Commercial Distribution
GS105000223441821 [Package]
Package: Case 66250706 [5 Units]
In Commercial Distribution
GS105000223498351 [Package]
Contains: 05000223441654
Package: Case 66250707 [1 Units]
In Commercial Distribution

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

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05000223504137 - BIOBRANE2025-03-10 BIOBRANE DRESSING 9.8INX15IN CTN 1 US
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05000223504120 - BIOBRANE2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)

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