UNiD_PASS B33236012-09

GUDID 03613720269632

UNiD CoCr D-ROD Ø6.0mm - 09

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720269632
• NIH Device Record Key: 9a28ef0d-9100-4860-b731-50a51de5a3c3
• Commercial Distribution Discontinuation: 2021-08-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: UNiD_PASS
• Version Model Number: B33236012-09
• Catalog Number: B33236012-09
• 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	03613720269632 [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

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

Moist Heat or Steam Sterilization

[03613720269632]

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: 2017-08-28

On-Brand Devices [UNiD_PASS]

• 03613720271215: UNiD Ti Rod Ø3.5mm - 10
• 03613720270874: UNiD Ti Dual Diameter Rod Ø3.5mm/Ø5.5mm - 14
• 03613720270492: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 23
• 03613720270485: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 22
• 03613720270478: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 21
• 03613720270461: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 20
• 03613720270454: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 19
• 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
• 03613720270409: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 14
• 03613720270393: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 13
• 03613720270386: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 12
• 03613720270379: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 11
• 03613720270362: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 09
• 03613720270355: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 08
• 03613720270348: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 07
• 03613720270331: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 06
• 03613720270324: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 05
• 03613720270317: UNiD CoCr Dual Diameter Rod Ø3.5mm/Ø6.0mm - 04
• 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