OviTex®

GUDID 00810055070978

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

• Primary Device ID: 00810055070978
• NIH Device Record Key: efdf3bd1-bc0f-458f-b01f-bf188ffa7f4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OviTex®
• Version Model Number: F10375-1712T
• Company DUNS: 078721472
• Company Name: TELA BIO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com
• Phone: 1-844-835-2246
• Email: customerservice@telabio.com

Device Dimensions

• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter
• Length: 17 Centimeter
• Width: 12 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055070978 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

[00810055070978]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-27
• Device Publish Date: 2024-08-19

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