DEVICE: Endoform Surface (09421904065680)
Device Identifier (DI) Information
Endoform Surface
SR05LG1010
Not in Commercial Distribution
AROA BIOSURGERY LIMITED
SR05LG1010
Not in Commercial Distribution
AROA BIOSURGERY LIMITED
Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
45023 | Animal-derived wound matrix dressing |
A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.
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Active | false |
60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial |
A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KGN | Dressing, Wound, Collagen |
FTM | Mesh, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162461 | 000 |
K171231 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 59 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 10 x 10 cm |
Device Record Status
172d0fb4-4296-4656-a56e-bd83b92104c3
July 21, 2025
9
July 02, 2018
July 21, 2025
9
July 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
860-337-7730
customerservice@appulsemed.com
customerservice@appulsemed.com