Medicrea|UNiD ROD

GUDID 03613720287568

UNiD Ti Rod 4.75mm 1-3 LV

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: 03613720287568
• NIH Device Record Key: ad499f6a-6f4b-41f0-95ad-347400f7c546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medicrea|UNiD ROD
• Version Model Number: B33124712-01
• 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	03613720287568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220724

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

Moist Heat or Steam Sterilization

[03613720287568]

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 ROD]

• 03613720287636: UNiD CoCr Dual Diameter Rod 4.75/6.0mm
• 03613720287629: UNiD CoCr Dual Diameter Rod 4.75/5.5mm
• 03613720287612: UNiD CoCr Rod 4.75mm 1-3 LV
• 03613720287605: UNiD Ti Dual Diameter Rod 4.75mm/6.0mm
• 03613720287599: UNiD Ti Dual Diameter Rod 4.75mm/5.5mm
• 03613720287568: UNiD Ti Rod 4.75mm 1-3 LV
• 03613720287513: UNiD CoCr Rod 4.75mm 4+ LV
• 03613720287506: UNiD Ti Rod 4.75mm 4+ LV
• 03613720289814: UNID EXP B33245699-01 5.5/6.0 CC
• 03613720289791: UNID EXP B33244699-01 DUAL 4.75/6.0 CC
• 03613720289777: UNID EXP B33244599-01 DUAL 4.75/5.5 CC
• 03613720289753: UNID EXP B33236099-01 6.0 CC DROD
• 03613720289739: UNID EXP B33226099-02 6.0 CC ROD 4UPL
• 03613720289715: UNID EXP B33226099-01 6.0 CC ROD 1-3 L
• 03613720289692: UNID EXP B33225599-02 5.5 CC ROD 4UPL
• 03613720289678: UNID EXP B33225599-01 5.5 CC ROD 1-3 L
• 03613720289654: UNID EXP B33224799-02 4.75 CC ROD 4UPL
• 03613720289630: UNID EXP B33224799-01 4.75 CC ROD 1-3L
• 03613720289616: UNID EXP B33145699-01 5.5/6.0 TI
• 03613720289593: UNID EXP B33144699-01 DUAL 4.75/6.0 TI
• 03613720289579: UNID EXP B33144599-01 DUAL 4.75/5.5 TI
• 03613720289555: UNID EXP B33136099-01 6.0 TI DROD
• 03613720289531: UNID EXP B33126099-02 6.0 TI ROD 4UP L
• 03613720289517: UNID EXP B33126099-01 6.0 TI ROD 1-3 L
• 03613720289494: UNID EXP B33125599-02 5.5 TI ROD 4UP L
• 03613720289470: UNID EXP B33125599-01 5.5 TI ROD 1-3 L
• 03613720289456: UNID EXP B33124799-02 4.75 TI ROD 4UPL
• 03613720289432: UNID EXP B33124799-01 4.75 TI ROD 1-3L