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TAPESTRY BIointegrative Implant with Insertion Sleeve

FDA UDI

Class II (US FDA UDI)

by Embody, Inc.

Identity

Trade Name
TAPESTRY BIointegrative Implant with Insertion Sleeve FDA UDI
Generic Name
Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Model / Reference
TP-7050-02 FDA UDI

Identifiers

Primary DI / UDI-DI
00810063820008 FDA UDI
510(k) Number
K201572 FDA UDI
FDA Product Code
OWY FDA UDI
FTM 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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Width — 70 Millimeter FDA UDI
Height — 50 Millimeter FDA UDI

Category: Extra-gynaecological surgical mesh, biologic-polymer composite

TAPESTRY BIointegrative Implant with Insertion Sleeve 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 f9eeb171-a7f1-47f8-9dc0-b61be1e257b4 36 fields · synced May 30, 2026