Medicrea|UNiD OCT

GUDID 03613720287650

UNiD Ti Dual Diameter Rod 3.5mm/4.75mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720287650
• NIH Device Record Key: 49cb880f-55ff-46ff-aaca-b7ccb9215493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medicrea|UNiD OCT
• Version Model Number: B33143400-01
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720287650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220810

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

[03613720287650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [Medicrea|UNiD OCT]

• 03613720287674: UNiD CoCr Dual Diameter Rod 3.5/4.75mm
• 03613720287650: UNiD Ti Dual Diameter Rod 3.5mm/4.75mm
• 03613720290018: UNID EXP B33243699-01 DUAL 3.5/6.0 CC
• 03613720289999: UNID EXP B33243599-01 DUAL 3.5/5.5 CC
• 03613720289975: UNID EXP B33243499-01 DUAL 3.5/4.75 CC
• 03613720289951: UNID EXP B33223599-02 3.5 CC ROD 4UPL
• 03613720289937: UNID EXP B33223599-01 3.5 CC ROD 1-3 L
• 03613720289913: UNID EXP B33143699-01 DUAL 3.5/6.0 TI
• 03613720289890: UNID EXP B33143599-01 DUAL 3.5/5.5 TI
• 03613720289876: UNID EXP B33143499-01 DUAL 3.5/4.75 TI
• 03613720289852: UNID EXP B33123599-02 3.5 TI ROD 4UP L
• 03613720289838: UNID EXP B33123599-01 3.5 TI ROD 1-3L