HOFFMANN 4960-3-015

GUDID 04546540492814

O-Ring A+P ORM.0045.10

Stryker GmbH

External orthopaedic fixation system, reusable

• Primary Device ID: 04546540492814
• NIH Device Record Key: f8d143ec-9997-4904-b5a7-6ee1d5bf08c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOFFMANN
• Version Model Number: 4960-3-015
• Catalog Number: 4960-3-015
• Company DUNS: 481999654
• Company Name: Stryker GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540492814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050048

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

[04546540492814]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-14
• Device Publish Date: 2021-11-17

On-Brand Devices [HOFFMANN]

• 07613154691340: Spanner Wrench - 8mm
• 07613154691333: Thumbwheel - 8mm
• 07613154691326: Torque Wrench - 8mm 11Nm
• 04546540492814: O-Ring A+P ORM.0045.10