33 B33126012

GUDID 03613720205760

UNiD Ti ROD Ø6.0mm >120mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720205760
• NIH Device Record Key: cc73001d-c4ae-4487-89f2-7d4a97c6a2d1
• Commercial Distribution Discontinuation: 2021-08-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 33
• Version Model Number: PASS LP
• Catalog Number: B33126012
• 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	03613720205760 [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

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

Moist Heat or Steam Sterilization

[03613720205760]

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: 2015-10-23

On-Brand Devices [33]

• 03613720205920: UNiD CoCr D-ROD Ø6.0 mm >120mm
• 03613720205883: UNiD CoCr ROD Ø6.0mm >120mm
• 03613720205845: UNiD CoCr ROD Ø5.5mm
• 03613720205807: UNiD Ti D-ROD Ø6.0 mm >120mm
• 03613720205760: UNiD Ti ROD Ø6.0mm >120mm
• 03613720205715: UNiD Ti ROD Ø5.5mm >120mm
• 03613720205906: UNiD CoCr D-ROD Ø6.0 mm
• 03613720205869: UNiD CoCr ROD Ø6.0mm
• 03613720205821: UNiD CoCr ROD Ø5.5mm
• 03613720205784: UNiD Ti D-ROD Ø6.0 mm
• 03613720205746: UNiD Ti ROD Ø6.0mm
• 03613720205692: UNiD Ti ROD Ø5.5 mm