VERASENSE Handle 03000-501

GUDID 00816818020372

ORTHOSENSOR INC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00816818020372
• NIH Device Record Key: 3f74917f-70a2-4fd0-8a2e-c0f319e8b017
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERASENSE Handle
• Version Model Number: VERASENSE Handle
• Catalog Number: 03000-501
• Company DUNS: 005788130
• Company Name: ORTHOSENSOR 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816818020372 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

[00816818020372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-23

Devices Manufactured by ORTHOSENSOR INC

• 00816818021478 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021485 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021492 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021508 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021515 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021522 - VERASENSE for Zimmer Biomet Persona: 2023-05-03
• 00816818021539 - VERASENSE for Stryker Triathlon: 2023-05-03
• 00816818021546 - VERASENSE for Stryker Triathlon: 2023-05-03