228143

GUDID 10886705010059

Meniscal Deployment Gun with Malleable Graft Retractor

DEPUY MITEK, LLC

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use

• Primary Device ID: 10886705010059
• NIH Device Record Key: 7bd706d5-4351-482a-b5ee-0a454d70d0a5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 228143
• Catalog Number: 228143
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705010059 [Primary]

FDA Product Code

• GEF: APPLIER, STAPLE, SURGICAL,

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: 2020-02-06
• Device Publish Date: 2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

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• 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