COUGAR 187105214

GUDID 10705034135458

COUGAR SYSTEM ANTERIOR, MEDIUM 14mm, 5 DEGREES

DEPUY SPINE, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 10705034135458
• NIH Device Record Key: af683fe3-7a91-42ca-a1c6-18d07ca546cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COUGAR
• Version Model Number: 187105214
• Catalog Number: 187105214
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• 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: 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)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034135458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030833

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10705034135458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-24

On-Brand Devices [COUGAR]

• 10705034360188: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM INSERTION SHIM - LEFT BLADE
• 10705034360171: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM INSERTION SHIM - RIGHT BLADE
• 10705034360157: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM GRAFT RETAINMENT 16mm
• 10705034360140: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM GRAFT RETAINMENT 14mm
• 10705034360133: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM GRAFT RETAINMENT 12mm
• 10705034360126: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM GRAFT RETAINMENT 10mm
• 10705034360119: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM GRAFT RETAINMENT 8mm
• 10705034360096: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED STRAIGHT INSERTER
• 10705034217215: COUGAR LS LATERAL CAGE SYSTEM IMPLANT REMOVAL TOOL
• 10705034361185: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED RING CURETTE, FLAT 8mm
• 10705034361178: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED RING CURETTE, ROUND 8mm
• 10705034361116: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED UP BITING CURETTE, LEFT 6mm
• 10705034361109: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED CURETTE, LEFT 6mm
• 10705034361093: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED UP BITING CURETTE, RIGHT 6mm
• 10705034361086: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED CURETTE, RIGHT 6mm
• 10705034360966: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED COBB, LEFT 18mm
• 10705034360959: COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED COBB, RIGHT 18mm
• 10705034135939: COUGAR SYSTEM LARGE IMPLANT 20mm, 15 DEGREES
• 10705034135922: COUGAR SYSTEM LARGE IMPLANT 18mm, 15 DEGREES
• 10705034135915: COUGAR SYSTEM LARGE IMPLANT 16mm, 15 DEGREES
• 10705034135908: COUGAR SYSTEM LARGE IMPLANT 14mm, 15 DEGREES
• 10705034135892: COUGAR SYSTEM IMPLANT - LARGE 15 DEGREES 12mm
• 10705034135885: COUGAR SYSTEM MEDIUM IMPLANT 20mm, 15 DEGREES
• 10705034135878: COUGAR SYSTEM MEDIUM IMPLANT 18mm, 15 DEGREES
• 10705034135861: COUGAR SYSTEM MEDIUM IMPLANT 16mm, 15 DEGREES
• 10705034135854: COUGAR SYSTEM MEDIUM IMPLANT 14mm, 15 DEGREES
• 10705034135847: COUGAR SYSTEM IMPLANT - MEDIUM 15 DEGREES 12mm
• 10705034135830: COUGAR SYSTEM IMPLANT - MEDIUM 15 DEGREES 10mm
• 10705034135823: COUGAR SYSTEM SMALL IMPLANT 20mm, 15 DEGREES
• 10705034135816: COUGAR SYSTEM SMALL IMPLANT 18mm, 15 DEGREES
• 10705034135809: COUGAR SYSTEM SMALL IMPLANT 16mm, 15 DEGREES
• 10705034135793: COUGAR SYSTEM SMALL IMPLANT 14mm, 15 DEGREES
• 10705034135786: COUGAR SYSTEM IMPLANT - SMALL 15 DEGREES 12mm
• 10705034135779: COUGAR SYSTEM IMPLANT - SMALL 15 DEGREES 10mm
• 10705034135755: COUGAR SYSTEM ANTERIOR, LARGE IMPLANT 18mm, 10 DEGREES
• 10705034135748: COUGAR SYSTEM ANTERIOR, LARGE IMPLANT 16mm, 10 DEGREES
• 10705034135731: COUGAR SYSTEM ANTERIOR, LARGE IMPLANT 14mm, 10 DEGREES
• 10705034135724: COUGAR SYSTEM ANTERIOR, LARGE IMPLANT 12mm, 10 DEGREES
• 10705034135694: COUGAR SYSTEM ANTERIOR, MEDIUM 20mm, 10 DEGREES
• 10705034135687: COUGAR SYSTEM ANTERIOR, MEDIUM 18mm, 10 DEGREES
• 10705034135670: COUGAR SYSTEM ANTERIOR, MEDIUM 16mm, 10 DEGREES
• 10705034135663: COUGAR SYSTEM ANTERIOR, MEDIUM 14mm, 10 DEGREES
• 10705034135656: COUGAR SYSTEM ANTERIOR, MEDIUM 12mm, 10 DEGREES
• 10705034135649: COUGAR SYSTEM MEDIUM IMPLANT 11mm, 10 DEGREES
• 10705034135632: COUGAR SYSTEM MEDIUM IMPLANT 10mm, 10 DEGREES
• 10705034135625: COUGAR SYSTEM ANTERIOR, SMALL 20mm, 10 DEGREES
• 10705034135618: COUGAR SYSTEM ANTERIOR, SMALL 18mm, 10 DEGREES
• 10705034135601: COUGAR SYSTEM ANTERIOR, SMALL 16mm, 10 DEGREES
• 10705034135595: COUGAR SYSTEM ANTERIOR, SMALL 14mm, 10 DEGREES
• 10705034135588: COUGAR SYSTEM ANTERIOR, SMALL 12mm, 10 DEGREES