DEVICE: TAPESTRY Biointegrative Implant with Introducer (00810063820091)

Device Identifier (DI) Information

TAPESTRY Biointegrative Implant with Introducer
TR-2030-21
Not in Commercial Distribution
TR-2030-21
Embody, Inc.
00810063820091
GS1
April 30, 2025
1
079544913 *Terms of Use
TAPESTRY Biointegrative Implant with Introducer, Anterior, 20mm x 30mm
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Device Characteristics

MR Safe
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?
61545 Extra-gynaecological surgical mesh, biologic-polymer composite
A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. 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
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K220867 000
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

56254e2c-0ee2-4d82-839e-ae5521e618b9
May 30, 2025
5
June 01, 2022
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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

[?]
No Customer Contact currently defined
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