CovaWound™ Hydrocolloid 5x20 5000520

GUDID 00825439013410

Hydrocolloid Dressing

Covalon Technologies Ltd

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Primary Device ID	00825439013410
NIH Device Record Key	8502e7f4-9825-40d5-a689-645a4c466a57
Commercial Distribution Status	In Commercial Distribution
Brand Name	CovaWound™ Hydrocolloid 5x20
Version Model Number	5000520
Catalog Number	5000520
Company DUNS	206936101
Company Name	Covalon Technologies Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Dimensions

Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter
Length	5 Centimeter
Width	20 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439013403 [Primary]
GS1	00825439013410 [Package] Contains: 00825439013403 Package: Carton [10 Units] In Commercial Distribution

FDA Product Code

NAD	Dressing, Wound, Occlusive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-08-01
Device Publish Date	2023-07-24

Devices Manufactured by Covalon Technologies Ltd

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00825439011416 - CovaWound™ Silicone 12.5x12.5	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011430 - CovaWound™ Silicone 15x15	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011454 - CovaWound™ Silicone 15x20	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011478 - CovaWound™ Silicone 7.5x7.5	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439011515 - CovaWound™ Silicone 12x12	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439011553 - CovaWound™ Silicone 15x20	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439012055 - CovaWound™ Silicone 18x18	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border

Trademark Results [CovaWound]

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