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TAPESTRY Biointegrative Implant with Introducer

FDA UDI

Class II (US FDA UDI)

by Embody, Inc.

Identity

Trade Name
TAPESTRY Biointegrative Implant with Introducer FDA UDI
Generic Name
Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Device Name
TAPESTRY Biointegrative Implant with Introducer, Lateral, 20mm x 30mm FDA UDI
Model / Reference
TR-2030-31 FDA UDI
Description
TAPESTRY Biointegrative Implant with Introducer, Lateral, 20mm x 30mm FDA UDI

Identifiers

Catalog Number
TR-2030-31 FDA UDI
Primary DI / UDI-DI
00810063820121 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
Not 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
MRI Safety
MR Safe FDA UDI

TAPESTRY Biointegrative Implant with Introducer by Embody, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K220867 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Embody, Inc.

Sources (1)

  • FDA UDI d6da5e55-efab-4832-a148-f329dd241b63 36 fields · synced May 30, 2026