DEVICE: Sorbalgon Ag st 2g/30cm P5 (10612553018073)
Device Identifier (DI) Information
Sorbalgon Ag st 2g/30cm P5
999609
In Commercial Distribution
HARTMANN USA, INC.
999609
In Commercial Distribution
HARTMANN USA, INC.
Sorbalgon Ag st 2g/30cm P5
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FRO | Dressing, Wound, Drug |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a95c4db4-628f-426c-9bc6-346d8db6914e
June 26, 2023
2
September 01, 2020
June 26, 2023
2
September 01, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20612553018070 | 5 | 10612553018073 | In Commercial Distribution | ||
40612553018074 | 10 | 20612553018070 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined