Integra® UCHRHK

GUDID 10381780252498

Integra® Hardware Kit for UCHR

INTEGRA LIFESCIENCES CORPORATION

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 10381780252498
• NIH Device Record Key: 125235ac-fc0b-4038-996c-1061157de98a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: UCHRHK
• Catalog Number: UCHRHK
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780252498 [Previous]
GS1	10381780542292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160811

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

[10381780252498]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-11
• Device Publish Date: 2024-06-03

On-Brand Devices [Integra®]

• 10381780072522: 3 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide cont
• 10381780024460: 5 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide cont
• M248440C10121: Right Horseshoe Gel Pad and Base Assembly
• M248440C10111: Left Horseshoe Gel Pad and Base Assembly
• 10381780344766: Integra® 16.5" BRS RETRACTOR ARM
• 10381780252498: Integra® Hardware Kit for UCHR
• 10381780537519: Integra® External Drainage System
• 10381780537502: Integra® External Drainage System