DEVICE: Endoform Myriad (09421905067393)

Device Identifier (DI) Information

Endoform Myriad
MR05LG1020
Not in Commercial Distribution
SR05LG1020US
AROA BIOSURGERY LIMITED
09421905067393
GS1
November 01, 2023
1
594540572 *Terms of Use
09421904065697
Myriad 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 surround the tissue if desired.
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Device Characteristics

MR Safe
No
No
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 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.
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KGN Dressing, Wound, Collagen
FTL Mesh, Surgical, Polymeric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K162461 000
K171231 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 10 x 20 cm
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Device Record Status

f40dfe91-213d-4759-afcc-6594b5e58bd7
July 21, 2025
8
March 31, 2019
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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
No Package DIs found
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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
No
No CLOSE

Customer Contact

[?]
877-627-6224
customerservice@aroabio.com
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