T-Handle T23-116-1-4

GUDID 00854515008156

Unique Surgical

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00854515008156
• NIH Device Record Key: a95ee295-e07c-45f1-88a6-a96c72e4a893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Handle
• Version Model Number: Silicone, 1/4 Inch Square Connector
• Catalog Number: T23-116-1-4
• Company DUNS: 079820535
• Company Name: Unique Surgical
• 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: false
• 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

Customer Support Contacts

• Phone: 818-813-8527
• Email: info@UniqueSurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854515008156 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00854515008156]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-13
• Device Publish Date: 2023-01-05

Devices Manufactured by Unique Surgical

• 00854515008385 - Tibial Cutting Jig: 2023-06-30
• 00854515008323 - Patella Clamp: 2023-05-03
• 00854515008361 - Alignment Guide: 2023-05-03
• 00854515008101 - Lima Femoral Cutting Block: 2023-01-13
• 00854515008132 - Lima Femoral Cutting Block: 2023-01-13
• 00854515008149 - IM Rod: 2023-01-13
• 00854515008156 - T-Handle: 2023-01-13
• 00854515008156 - T-Handle: 2023-01-13
• 00854515008231 - Angled Drill Bit: 2023-01-13