DEVICE: ColActive® Plus 2"x2" (00825439011188)

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Device Record History
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Device Identifier (DI) Information
ColActive® Plus 2"x2"
5550220
In Commercial Distribution

Covalon Technologies Ltd
00825439011188
GS1

1
206936101 *Terms of Use
Collagen dressing
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45023 Collagen wound matrix dressing
A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRO Dressing, Wound, Drug
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K060804 000
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 2 Inch
Width: 2 Inch
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Device Record Status
03c476df-9ed1-4c32-a028-0e87f17ae85f
December 08, 2022
1
November 30, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00825439011195 10 00825439011188 In Commercial Distribution Carton
10825439011208 10 00825439011195 In Commercial Distribution Shipper
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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