Identity
- Trade Name
- Tapestry Biointegrative Implant FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
- Device Name
- Tapestry Biointegrative Implant, 30mm x 30mm FDA UDI
- Model / Reference
- TR-3030-01 FDA UDI
- Description
- Tapestry Biointegrative Implant, 30mm x 30mm FDA UDI
Identifiers
- Catalog Number
- TR-3030-01 FDA UDI
- Primary DI / UDI-DI
- 00810063820541 FDA UDI
- 510(k) Number
- K220867 FDA UDI
- FDA Product Code
- OWY FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Extra-gynaecological surgical mesh, biologic-polymer composite
Tapestry Biointegrative Implant by Embody, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, biologic-polymer composite.
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- OviTex® IHR — Aroa Biosurgery · Class II
- OviTex® PRS — TELA Bio, Inc. · Class II
- OviTex® PRS — TELA Bio, Inc. · Class II
- OviTex® PRS — TELA Bio, Inc. · Class II
- OviTex® PRS — TELA Bio, Inc. · Class II
Cleared under the same submission
K220867 also covers:
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- TAPESTRY Biointegrative Implant with Introducer — Embody, Inc.
- Tapestry Biointegrative Implant — Embody, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Embody, Inc.
Sources (1)
- FDA UDI 131c8160-8d0d-4734-88ed-99f74815ec37 35 fields · synced May 30, 2026