UNID ROD B33166000L-05

GUDID 03613720283485

UNiD Ti Ring Rod Ø6.0mm Left - 05

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 Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720283485
• NIH Device Record Key: a2a5f7d1-cd3c-406d-b32c-e8220349cb32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNID ROD
• Version Model Number: B33166000L-05
• Catalog Number: B33166000L-05
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03613720283485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140738

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

[03613720283485]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [UNID ROD]

• 03613720275831: UNiD Box
• 03613720283980: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 17
• 03613720283973: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 16
• 03613720283966: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 15
• 03613720283959: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 14
• 03613720283942: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 13
• 03613720283935: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 12
• 03613720283928: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 11
• 03613720283911: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 10
• 03613720283904: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 09
• 03613720283898: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 08
• 03613720283881: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 07
• 03613720283874: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 06
• 03613720283867: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 05
• 03613720283850: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 04
• 03613720283843: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 03
• 03613720283836: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 02
• 03613720283829: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 01
• 03613720283812: UNiD CoCr Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm
• 03613720283805: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 17
• 03613720283799: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 16
• 03613720283782: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 15
• 03613720283775: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 14
• 03613720283768: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 13
• 03613720283751: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 12
• 03613720283744: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 11
• 03613720283737: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 10
• 03613720283720: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 09
• 03613720283713: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 08
• 03613720283706: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 07
• 03613720283690: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 06
• 03613720283683: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 05
• 03613720283676: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 04
• 03613720283669: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 03
• 03613720283652: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 02
• 03613720283645: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 01
• 03613720283638: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm
• 03613720283577: UNiD Ti Ring Rod Ø5.5mm Right - 06
• 03613720283560: UNiD Ti Ring Rod Ø6.0mm Right - 06
• 03613720283553: UNiD Ti Ring Rod Ø6.0mm Right - 05
• 03613720283546: UNiD Ti Ring Rod Ø6.0mm Right - 04
• 03613720283539: UNiD Ti Ring Rod Ø6.0mm Right - 03
• 03613720283522: UNiD Ti Ring Rod Ø6.0mm Right - 02
• 03613720283515: UNiD Ti Ring Rod Ø6.0mm Right - 01
• 03613720283508: UNiD Ti Ring Rod Ø6.0mm Right
• 03613720283492: UNiD Ti Ring Rod Ø6.0mm Left - 06
• 03613720283485: UNiD Ti Ring Rod Ø6.0mm Left - 05
• 03613720283478: UNiD Ti Ring Rod Ø6.0mm Left - 04
• 03613720283461: UNiD Ti Ring Rod Ø6.0mm Left - 03
• 03613720283454: UNiD Ti Ring Rod Ø6.0mm Left - 02