Handle 53013

GUDID 09120047299500

AO Handle

I.T.S. GmbH

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 09120047299500
• NIH Device Record Key: feac5357-be35-423d-ad89-47c1ef468220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handle
• Version Model Number: 53013
• Catalog Number: 53013
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120047299500 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

[09120047299500]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-01
• Device Publish Date: 2018-10-24

On-Brand Devices [Handle]

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• 09120047308233: Handle, Cannulated Tibia Nail
• 09120047300336: Handle, Proximal Humeral Plate
• 09120047297087: Handle, Left, Proximal Lateral Tibia Plate
• 09120047297070: Handle, Right, Proximal Lateral Tibia Plate
• 09120069810660: AO Silicone Handle
• 09120047299500: AO Handle
• 09120034303807: Handle, 25mm, AO Connector