212114

GUDID 10886705001927

Super / RC Inserter

DEPUY MITEK, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10886705001927
• NIH Device Record Key: e1bde223-667b-4ad1-ac2c-c4f2a32f0ebe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 212114
• Catalog Number: 212114
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	10886705001927 [Primary]

FDA Product Code

• GEF: APPLIER, STAPLE, SURGICAL,

Sterilization

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

[10886705001927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

• 10886705010905 - TARGET: 2024-04-03 TARGET TENDON HARVESTER INSTRUMENT
• 10886705010912 - TARGET: 2024-04-03 TARGET DISPOSABLE CUTTING TIPS
• 10886705020591 - FMS VUE: 2024-03-25 FMS VUE Fluid Management System
• 10886705013616 - INTRAFIX: 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 7mm Sheath and (1) 6mm Screw 7mm-7.5mm x 23mm
• 10886705013623 - INTRAFIX: 2023-11-02 FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm
• 10886705013630 - INTRAFIX: 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 8mm Sheath and (1) 7mm Screw 8mm-8.5mm x 23mm
• 10886705013647 - INTRAFIX: 2023-11-02 FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm
• 10886705013654 - INTRAFIX: 2023-11-02 FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm