OviTex®

GUDID 00856072005272

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.

TELA BIO, INC.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable
Primary Device ID00856072005272
NIH Device Record Key008821ba-d21a-402b-8c5a-38c957342e11
Commercial Distribution StatusIn Commercial Distribution
Brand NameOviTex®
Version Model NumberF10269-1015T
Company DUNS078721472
Company NameTELA BIO, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com
Phone1-844-835-2246
Emailcustomerservice@telabio.com

Device Dimensions

Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter
Length10 Centimeter
Width15 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100856072005272 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


[00856072005272]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-29
Device Publish Date2020-10-21

On-Brand Devices [OviTex® ]

00856072005272The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005548The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005531The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005555The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005579The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005562The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005586The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005623The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005616The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00810055070923The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00810055070916The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005630The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005654The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin
00856072005647The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin

Trademark Results [OviTex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OVITEX
OVITEX
86761323 5065654 Live/Registered
TELA Bio, Inc.
2015-09-18

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