DEVICE: Sorbalgon Ag st 10x10cm P10 (10612553018097)

Device Identifier (DI) Information

Sorbalgon Ag st 10x10cm P10
999611
In Commercial Distribution

HARTMANN USA, INC.
10612553018097
GS1

1
010137511 *Terms of Use
Sorbalgon Ag st 10x10cm P10
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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?
47045 Cavity-wound management dressing, antimicrobial
A non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent), and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4dd2be7f-72a4-446f-95a4-69706e6c2ab0
June 26, 2023
2
September 01, 2020
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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
20612553018094 10 10612553018097 In Commercial Distribution
40612553018098 5 20612553018094 In Commercial Distribution
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Secondary DI

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

[?]
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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