CovaWound™ Silicone 10x10

GUDID 00825439011492

Self-Adherent Soft Silicone Foam Dressing

Covalon Technologies Ltd

Exudate-absorbent dressing, non-gel, non-antimicrobial
Primary Device ID00825439011492
NIH Device Record Key7fa6e910-00a9-4cfd-a36e-fcbe9a7c6d8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCovaWound™ Silicone 10x10
Version Model Number1001010
Company DUNS206936101
Company NameCovalon Technologies Ltd
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter
Length10 Centimeter
Width10 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100825439011485 [Primary]
GS100825439011492 [Package]
Contains: 00825439011485
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-12
Device Publish Date2024-04-04

On-Brand Devices [CovaWound™ Silicone 10x10]

00825439011492Self-Adherent Soft Silicone Foam Dressing
00825439014370Self-Adherent Soft Silicone Foam Dressing with Border (Lite)
00825439011393Self-Adherent Soft Silicone Foam Dressing with Border

Trademark Results [CovaWound]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COVAWOUND
COVAWOUND
86534190 5223607 Live/Registered
Covalon Technologies Ltd.
2015-02-13

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