PROFILE 230425

GUDID 10886705010479

PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 25mm

DEPUY MITEK, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705010479
• NIH Device Record Key: ff040f55-bed1-41c3-adcd-778382ea284a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFILE
• Version Model Number: 230425
• Catalog Number: 230425
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705010479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961234

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-08-30
• Device Publish Date: 2015-09-01

On-Brand Devices [PROFILE]

• 10886705010516: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 9 x 30mm
• 10886705010509: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 9 x 25mm
• 10886705010493: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 9 x 20mm
• 10886705010486: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 30mm
• 10886705010479: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 25mm
• 10886705010462: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 8 x 20mm
• 10886705010455: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 7 x 30mm
• 10886705010448: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 7 x 25mm
• 10886705010431: PROFILE CANNULATED INTERFERENCE SCREW ROUND HEAD 7 x 20mm