ALLEN WRENCH 8MM ROSAS00536

GUDID 00889024679559

Hexagonal key for installing Leksell frame adaptor.

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 00889024679559
• NIH Device Record Key: 23d1806a-37fd-433b-b383-a7d027cab795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLEN WRENCH 8MM
• Version Model Number: 151124
• Catalog Number: ROSAS00536
• Company DUNS: 264502977
• Company Name: MEDTECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com
• Phone: 1-800-348-2759
• Email: product.experience@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024679559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231103

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

[00889024679559]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-23
• Device Publish Date: 2025-07-15

Devices Manufactured by MEDTECH

• 00889024679559 - ALLEN WRENCH 8MM: 2025-07-23Hexagonal key for installing Leksell frame adaptor.
• 00889024679559 - ALLEN WRENCH 8MM: 2025-07-23 Hexagonal key for installing Leksell frame adaptor.
• 00887868539978 - SEEG DRILL ADAPTOR 2.70MM: 2025-07-16 Seeg Drill Adaptor Ø2.70 mm instrument Rosa 3.1 (brain application) stainless steel instrument adaptor for drilling
• 00889024671102 - PLANNING STATION - ROSA ONE - USA: 2024-05-28 Planning Station DELL 7520 Qwerty power plug B for Rosa One
• 00887868540028 - ROBOT ARM INTERFACE: 2024-02-28 Robot Arm Interface ROSA One
• 00889024663282 - PLANNING STATION - ROSA ONE - USA: 2024-02-28 Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7
• 03760244031129 - Trnsnsl Endscp Ovoid Ø6.18mm Holder: 2023-11-06 Trnsnsl Endscp Ovoid Ø6.18mm Holder instrument Rosa 3.1 (Brain application) instrument holder for guidance of a Storz sheath 72
• 00887868585951 - ROSA ONE SURGICAL ASSISTANT (US): 2023-10-24 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B
• 03760244034793 - ROSA ONE SURGICAL ASSISTANT (US): 2022-06-28 Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B