TELIGEN 286006061S

GUDID 10705034604510

TELIGEN VUE CAMERA

DEPUY SPINE, LLC

Endoscope video camera

• Primary Device ID: 10705034604510
• NIH Device Record Key: 950a79a1-b2a0-4d3d-9891-23c8bdc2d549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TELIGEN
• Version Model Number: 286006061S
• Catalog Number: 286006061S
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034604510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213978

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-12
• Device Publish Date: 2024-02-10

Devices Manufactured by DEPUY SPINE, LLC

• 10705034578835 - N/A: 2025-09-03 DRILL TAP SCREW GUIDE
• 10705034578842 - N/A: 2025-09-03 DRILL TAP SCREW GUIDE
• 10705034584164 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5-6mm
• 10705034584171 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5-6mm
• 10705034587240 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5-6mm
• 10705034587257 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5-6mm
• 10705034587561 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5mm x 40mm
• 10705034587578 - TRIALTIS: 2025-07-25 ø5.5-6mm to 5.5mm x 60mm