NEUFLEX 123420000

GUDID 10603295017967

NEUFLEX MCP FINGER IMPLANT 20 CEMENTLESS

DEPUY ORTHOPAEDICS, INC.

Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece

• Primary Device ID: 10603295017967
• NIH Device Record Key: de9dd3c9-d83a-4ddb-aa26-333cd1398863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEUFLEX
• Version Model Number: 1234-20-000
• Catalog Number: 123420000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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: 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
• 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
• 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
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295017967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970544

FDA Product Code

• KYJ: PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2015-09-24

On-Brand Devices [NEUFLEX]

• 10603295017950: NEUFLEX MCP FINGER IMPLANT 10 CEMENTLESS
• 10603295018001: NEUFLEX MCP FINGER IMPLANT 60 CEMENTLESS
• 10603295017998: NEUFLEX MCP FINGER IMPLANT 50 CEMENTLESS
• 10603295017981: NEUFLEX MCP FINGER IMPLANT 40 CEMENTLESS
• 10603295017974: NEUFLEX MCP FINGER IMPLANT 30 CEMENTLESS
• 10603295017967: NEUFLEX MCP FINGER IMPLANT 20 CEMENTLESS
• 10603295017943: NEUFLEX MCP FINGER IMPLANT 0 CEMENTLESS
• 10603295149842: NEUFLEX MCP INSTRUMENT TRAY
• 10603295149590: NEUFLEX PIP INSTRUMENT CASE
• 10603295149828: NEUFLEX MCP RASP/AWL
• 10603295149804: NEUFLEX MCP BROACH DISTAL SIZE 60
• 10603295149798: NEUFLEX MCP BROACH PROX SIZE 60
• 10603295149781: NEUFLEX MCP TRIAL SIZE 60
• 10603295149774: NEUFLEX MCP BROACH DISTAL SIZE 50
• 10603295149767: NEUFLEX MCP BROACH PROX SIZE 50
• 10603295149750: NEUFLEX MCP TRIAL SIZE 50
• 10603295149743: NEUFLEX MCP BROACH DISTAL SIZE 40
• 10603295149736: NEUFLEX MCP BROACH PROX SIZE 40
• 10603295149729: NEUFLEX MCP TRIAL SIZE 40
• 10603295149712: NEUFLEX MCP BROACH DISTAL SIZE 30
• 10603295149705: NEUFLEX MCP BROACH PROX SIZE 30
• 10603295149699: NEUFLEX MCP TRIAL SIZE 30
• 10603295149682: NEUFLEX MCP BROACH DISTAL SIZE 20
• 10603295149675: NEUFLEX MCP BROACH PROX SIZE 20
• 10603295149668: NEUFLEX MCP TRIAL SIZE 20
• 10603295149651: NEUFLEX MCP BROACH DISTAL SIZE 10
• 10603295149644: NEUFLEX MCP BROACH PROX SIZE 10
• 10603295149637: NEUFLEX MCP TRIAL SIZE 10
• 10603295149620: NEUFLEX MCP BROACH DISTAL SIZE 0
• 10603295149613: NEUFLEX MCP BROACH PROX SIZE 0
• 10603295149606: NEUFLEX MCP TRIAL SIZE 0
• 10603295149583: NEUFLEX PIP BROACH DISTAL SIZE 5
• 10603295149576: NEUFLEX PIP BROACH PROX SIZE 5
• 10603295149569: NEUFLEX PIP TRIAL SIZE 5
• 10603295149552: NEUFLEX PIP BROACH DISTAL SIZE 4
• 10603295149545: NEUFLEX PIP BROACH PROX SIZE 4
• 10603295149538: NEUFLEX PIP TRIAL SIZE 4
• 10603295149521: NEUFLEX PIP BROACH DISTAL SIZE 3
• 10603295149514: NEUFLEX PIP BROACH PROX SIZE 3
• 10603295149491: NEUFLEX PIP TRIAL SIZE 3
• 10603295149484: NEUFLEX PIP BROACH DISTAL SIZE 2
• 10603295149477: NEUFLEX PIP BROACH PROX SIZE 2
• 10603295149460: NEUFLEX PIP TRIAL SIZE 2
• 10603295149453: NEUFLEX PIP BROACH DISTAL SIZE 1
• 10603295149446: NEUFLEX PIP BROACH PROX SIZE 1
• 10603295149439: NEUFLEX PIP TRIAL SIZE 1
• 10603295017936: NEUFLEX FINGER-PIP IMPLANT 5 CEMENTLESS
• 10603295017929: NEUFLEX FINGER-PIP IMPLANT 4 CEMENTLESS
• 10603295017912: NEUFLEX FINGER-PIP IMPLANT 3 CEMENTLESS
• 10603295017905: NEUFLEX FINGER-PIP IMPLANT 2 CEMENTLESS