RESTORE 219367

GUDID 10886705006052

RESTORE OFFSET PIN GUIDE

DEPUY MITEK, LLC

Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable

• Primary Device ID: 10886705006052
• NIH Device Record Key: e8cdd5d2-f429-402d-bb39-9792ad8b169e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORE
• Version Model Number: 219367
• Catalog Number: 219367
• 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
• 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	10886705006052 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

[10886705006052]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-03-17

On-Brand Devices [RESTORE]

• 10886705006137: RESTORE Screw-Out For Small Hex
• 10886705006021: RESTORE INTRODUCER-LATERAL PORTAL
• 10886705006014: RESTORE INTRODUCER-MEDIAL PORTAL
• 10886705005949: RESTORE PIN PULLER
• 10886705005635: RESTORE CUP CURETTE
• 10886705005628: RESTORE RING CURETTE 7mm
• 10886705005611: RESTORE RING CURETTE 4mm
• 10886705005703: RESTORE ARTICULAR CARTILAGE AWL 90 Degrees
• 10886705005697: RESTORE TIBIAL AWL ROUND 90 Degrees
• 10886705005680: RESTORE FEMORAL AWL 45 Degree
• 10886705005666: RESTORE GRAFT HARVEST GOUGE
• 10886705005604: RESTORE ARTHROSCOPIC GOUGE
• 10886705005581: RESTORE OSTEOTOME WITH MM SCALE 5mm
• 10886705005574: RESTORE FLAT RASP
• 10886705005734: RESTORE BAYONET POINT PIN WITH EYELET .094 x 12 Inches (2.39mm x 30.5cm)
• 10886705005710: RESTORE ACL PATELLA RETRACTOR
• 10886705005727: RESTORE DRILL POINT PIN WITH EYELET .094 x 14 Inches (2.39mm x 35.6cm)
• 10886705010950: RESTORE GRAFT SIZER 8-12mm (Plus or Minus 2 Percent)
• 10886705005642: RESTORE CURVED RASP
• 10886705005987: RESTORE FEMORAL AIMER, 8mm OFFSET Percent ACCURACY=Plus or Minus 5 Percent
• 10886705005970: RESTORE FEMORAL AIMER, 7mm OFFSET Percent ACCURACY=Plus or Minus 5 Percent
• 10886705005963: RESTORE FEMORAL AIMER, 6mm OFFSET Percent ACCURACY=Plus or Minus 5 Percent
• 10886705005956: RESTORE FEMORAL AIMER, 5mm OFFSET Percent ACCURACY=Plus or Minus 5 Percent
• 10886705006052: RESTORE OFFSET PIN GUIDE
• 10886705005758: RESTORE BAYONET POINT PIN WITH EYELET .094 x 18 Inches (2.39mm x 45.7cm)
• 10886705005567: RESTORE TIBIAL GUIDE WITH RATCHET Percent ACCURACY = Plus or Minus 10 Percent
• 10886705005543: RESTORE BAYONET POINT PIN WITH EYELET .094 x 14 Inches (2.39mm x 35.6cm)