DEVICE: Suprello (00850058790060)
Device Identifier (DI) Information
Suprello
Dispenser Box (2 mL Pre-Filled Syringe + Applicator Tip)
In Commercial Distribution
Gel4med, Inc.
Dispenser Box (2 mL Pre-Filled Syringe + Applicator Tip)
In Commercial Distribution
Gel4med, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No | |
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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? |
---|---|---|---|---|
64853 | Synthetic wound matrix dressing |
A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.
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Active | false |
60919 | Synthetic peptide haemostatic agent |
A sterile, bioabsorbable device containing synthetic peptides intended to be applied to a surgical site to rapidly facilitate local haemostasis primarily through formation of a peptide hydrogel; it does not contain an antimicrobial agent. It is typically available as an aqueous solution (e.g., prefilled syringe) that can be applied directly to the wound where it remains to be absorbed by the body. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | Wound Dressing With Animal-Derived Material(S) |
MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
FRO | Dressing, Wound, Drug |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K222025 | 000 |
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
7b4e27e1-88e2-47a6-963a-baaad804fdbd
April 02, 2025
1
March 25, 2025
April 02, 2025
1
March 25, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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