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Tapestry Biointegrative Implant

FDA UDI

Class II (US FDA UDI)

by Embody, Inc.

Identity

Trade Name
Tapestry Biointegrative Implant FDA UDI
Generic Name
Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Device Name
provided with insertion sleeve FDA UDI
Model / Reference
TS-4030-02 FDA UDI
Description
provided with insertion sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
00810063820077 FDA UDI
510(k) Number
K201572 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
MRI Safety
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.

Cleared under the same submission

K201572 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 48b6b8da-66b7-4881-8ff5-f100ea064d89 34 fields · synced Jun 8, 2026