UNiD_PASS B33143500-08

GUDID 03613720269762

UNiD Ti Dual Diameter Rod Ø3.5mm/Ø5.5mm - 08

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: 03613720269762
• NIH Device Record Key: d36b3f15-4842-45d3-ae05-ef8f8f899bfb
• Commercial Distribution Discontinuation: 2021-08-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: UNiD_PASS
• Version Model Number: B33143500-08
• Catalog Number: B33143500-08
• 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: 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	03613720269762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153169

FDA Product Code

• NKG: Orthosis, Cervical Pedicle Screw Spinal Fixation

Sterilization

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

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

[03613720269762]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-08-19
• Device Publish Date: 2017-06-12

On-Brand Devices [UNiD_PASS]

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• 03613720270447: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 18
• 03613720270430: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 17
• 03613720270423: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 16
• 03613720270416: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 15
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• 03613720270379: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 11
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• 03613720270355: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 08
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• 03613720270300: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 23
• 03613720270294: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 22
• 03613720270287: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 21
• 03613720270270: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 20
• 03613720270263: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 19
• 03613720270256: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 18
• 03613720270249: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 17
• 03613720270232: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 16
• 03613720270225: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 15
• 03613720270218: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 14
• 03613720270201: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 13
• 03613720270195: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 12
• 03613720270188: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 11
• 03613720270171: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 10
• 03613720270164: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 09
• 03613720270157: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 08
• 03613720270140: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 07
• 03613720270133: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 06
• 03613720270126: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 05
• 03613720270119: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø6.0mm - 04
• 03613720270102: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 23
• 03613720270096: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 22
• 03613720270089: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 21
• 03613720270072: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 20
• 03613720270065: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 19
• 03613720270058: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 18
• 03613720270041: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 17
• 03613720270034: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 16
• 03613720270027: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø5.5mm - 15