FDA.reportPublic FDA data

OviTex®

Primary DI
00810055070978
Brand
OviTex®
Company
TELA BIO, INC.
Model
F10375-1712T
Device 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.
Published
2024-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055070978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055070978008100550709788100550709780810055070978

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17Centimeter
Width12Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-835-2246customerservice@telabio.com

Regulatory Flags#

DUNS number
078721472
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055071203OviTex® F10381-0305TF10381-0305T2026-03-27
00810055071173OviTex® F10379-1317TF10379-1317T2025-12-05
00810055071166OviTex® F10378-0715TF10378-0715T2025-08-06
00810055071159OviTex® F10377-1515T2025-07-08
00810055070183OviTex® PRSP20163-1620GP20163-1620G2023-07-12
00810055070275OviTex® PRSP20163-2020GP20163-2020G2023-07-12
00810055070442OviTex® PRSP20363-2025GP20363-2025G2023-07-12
00810055070619OviTex® PRSP20263-0815GP20263-0815G2023-07-12
00810055070770OviTex® PRSP20263-1020GP20263-1020G2023-07-12
00810055070855OviTex® PRSP20263-1122GP20263-1122G2023-07-12
00810055071067OviTex® PRSP20463-2525GP20463-2525G2025-02-21
00810055071074OviTex® PRSP20363-2530GP20363-2530G2025-02-21
00856072005050OviTex® PRSR20143-0820PR20143-0820P2025-02-21
00856072005142OviTex® PRSR20243-1122P2022-01-04
00856072005043OviTex® PRSR20143-0416P2020-09-14
00856072005074OviTex® PRSR20143-2020P2020-09-14
00856072005135OviTex® PRSR20243-1018P2020-09-14
00856072005005OviTex® PRSR20152-1620G2020-05-15
00856072005012OviTex® PRSR20152-2020G2020-05-15
00856072005029OviTex® PRSR20252-0815G2020-05-15

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