Tensor Surgical 3000

GUDID 00850019153002

Reusable devices used as a kit to shuttle suture through bone

TENSOR SURGICAL, INC.

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850019153002
• NIH Device Record Key: 64af0ca7-c171-4b20-abf4-4322983ee917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tensor Surgical
• Version Model Number: 3000
• Catalog Number: 3000
• Company DUNS: 051885419
• Company Name: TENSOR SURGICAL, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019153002 [Primary]
GS1	00850019153088 [Unit of Use]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

[00850019153002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-17
• Device Publish Date: 2020-06-09

Devices Manufactured by TENSOR SURGICAL, INC.

• 00850019153187 - Tensor Surgical VersaTip Suture Shuttle: 2020-06-23 Device used for capturing suture and making repairs
• 00850019153002 - Tensor Surgical: 2020-06-17Reusable devices used as a kit to shuttle suture through bone
• 00850019153002 - Tensor Surgical: 2020-06-17 Reusable devices used as a kit to shuttle suture through bone