OviTex®

FDA UDI

Class I (US FDA UDI)

by TELA Bio, Inc.

Identity

Trade Name: OviTex® FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix. FDA UDI
Model / Reference: F10341-1016T FDA UDI
Description: The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810055070916 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 10 Centimeter FDA UDI
Length — 16 Centimeter FDA UDI

Category: Surgical implant template, reusable

OviTex® by TELA Bio, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: TELA Bio, Inc.

Sources (1)

FDA UDI 709080bc-9941-44a9-8496-0e3b03a09681 35 fields · synced May 30, 2026