Medicrea|UNiD MIS

GUDID 03613720290070

UNID EXP B33155599-01 TI PERC 5.5 1-3L

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 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: 03613720290070
• NIH Device Record Key: 1a012e63-51f4-46b2-b2cf-57bc937354a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medicrea|UNiD MIS
• Version Model Number: B33155599-01
• 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
• 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	03613720290070 [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

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

[03613720290070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [Medicrea|UNiD MIS]

• 03613720287582: UNiD CoCr Perc Rod 4.75mm 1-3 LV
• 03613720287575: UNiD Ti Percutaneous Rod 4.75mm 1-3 LV
• 03613720287537: UNiD CoCr Percutaneous Rod 4.75mm 4+ LV
• 03613720287520: UNiD Ti Percutaneous Rod 4.75mm 4+ LV
• 03613720290254: UNID EXP B33256099-02 CC PERC 6.0 4UPL
• 03613720290230: UNID EXP B33256099-01 CC PERC 6.0 1-3L
• 03613720290216: UNID EXP B33255599-02 CC PERC 5.5 4UPL
• 03613720290193: UNID EXP B33255599-01 CC PERC 5.5 1-3L
• 03613720290179: UNID EXP B33254799-02 CC PERC 4.75 4UPL
• 03613720290155: UNID EXP B33254799-01 CC PERC 4.75 1-3L
• 03613720290131: UNID EXP B33156099-02 TI PERC 6.0 4UPL
• 03613720290117: UNID EXP B33156099-01 TI PERC 6.0 1-3L
• 03613720290094: UNID EXP B33155599-02 TI PERC 5.5 4UPL
• 03613720290070: UNID EXP B33155599-01 TI PERC 5.5 1-3L
• 03613720290056: UNID EXP B33154799-02 TI PERC 4.75 4UPL
• 03613720290032: UNID EXP B33154799-01 TI PERC 4.75 1-3L