UNIVERSAL 2 92-20500

GUDID 07613327554762

TAP FOR TROCAR HANDLE 99-01502

Stryker Leibinger GmbH & Co. KG

Fluted surgical drill bit, single-use

• Primary Device ID: 07613327554762
• NIH Device Record Key: 791b75b3-19b6-406b-8456-5280bf019133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL 2
• Version Model Number: 92-20500
• Catalog Number: 92-20500
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: false
• 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	07613327554762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070876

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

[07613327554762]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-03
• Device Publish Date: 2021-05-26

On-Brand Devices [UNIVERSAL 2]

• 07613327559316: MINI PLATE
• 07613327559293: MINI PLATE
• 07613327554762: TAP FOR TROCAR HANDLE 99-01502