TELIGEN 286006063S

GUDID 10705034604534

TELIGEN REDUCED ACCESS WITH SOFT TISSUE RETRACTOR

Medos International Sàrl

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10705034604534
• NIH Device Record Key: e7564ac2-dedf-47cb-926c-d9c734151720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TELIGEN
• Version Model Number: 286006063S
• Catalog Number: 286006063S
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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	10705034604534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213978

FDA Product Code

• LXH: Orthopedic manual surgical instrument

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

On-Brand Devices [TELIGEN]

• 10705034560519: TELIGEN Table Mount Adapter Screw
• 10705034560502: TELIGEN Table Mount Adapter Fork
• 10705034560441: TELIGEN Graft Delivery Cannula
• 10705034548739: TELIGEN Port Adjuster
• 10705034548722: TELIGEN Port Cutter
• 10705034548715: TELIGEN Dilator Large
• 10705034548708: TELIGEN Dilator Medium
• 10705034548692: TELIGEN Dilator Small
• 10705034548685: TELIGEN Table Mount Adapter Quick
• 10705034548678: TELIGEN Locking Arm
• 10705034548630: TELIGEN Case Lid
• 10705034548623: TELIGEN Lower Tray
• 10705034548616: TELIGEN Upper Tray
• 10705034548609: TELIGEN Case Base
• 10705034548913: TELIGEN Graft Delivery Cannula Navigated
• 10705034571607: TELIGEN Procedure Kit
• 10705034560526: TELIGEN HD CAMERA CONTROL SYSTEM
• 10705034555164: TELIGEN PEDAL LENS CLEANING
• 10705034555157: TELIGEN CAMERA WASH BOX US
• 10705034599861: TELIGEN CART ASSEMBLED
• 10705034560359: TELIGEN Procedure Kit Pro
• 10705034604558: TELIGEN ACCESS PROBE WITH STIMULATION WIRE
• 10705034604527: TELIGEN ACCESS PROBE
• 10705034604541: TELIGEN REDUCED ACCESS
• 10705034604534: TELIGEN REDUCED ACCESS WITH SOFT TISSUE RETRACTOR