IMPIX-C MS1112140

GUDID 03613720207191

IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 12mm

MEDICREA INTERNATIONAL

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• Primary Device ID: 03613720207191
• NIH Device Record Key: 2469fea3-cc1a-471d-b596-67f2ebdd089d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX-C
• Version Model Number: MS1112140
• Catalog Number: MS1112140
• 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	03613720207191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072226

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-08-05
• Device Publish Date: 2015-10-23

On-Brand Devices [IMPIX-C]

• 03613720224952: IMPIX-C HOLDER
• 03613720221272: SCREWDRIVER FOR CERVICAL DISTRACTOR PINS
• 03613720225317: SMALL CURETTE
• 03613720240365: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 10mm
• 03613720240358: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 9mm
• 03613720240341: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 8mm
• 03613720240334: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 7mm
• 03613720240327: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 6mm
• 03613720240310: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 5mm
• 03613720240303: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 4mm
• 03613720240297: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 9mm
• 03613720240280: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 8mm
• 03613720240273: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 7mm
• 03613720240266: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 6mm
• 03613720240259: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 5mm
• 03613720207191: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 12mm
• 03613720207160: IMPIX-C CERVICAL CAGE 14.5mm x 16mm x 11mm
• 03613720240242: IMPIX-C CERVICAL CAGE 12.5mm x 14mm x 4mm
• 03613720225942: DISPLAYING CASE IMPIX-C
• 03613720225775: CUTTER FOR IMPIX-C 14.5 x 16 x 4 mm
• 03613720225713: CUTTER FOR IMPIX-C 12.5 x 14 x 4 mm
• 03613720225652: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 4mm
• 03613720225607: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 10mm
• 03613720225591: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 4mm
• 03613720225584: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 9mm
• 03613720225577: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 8mm
• 03613720225553: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 9mm
• 03613720225546: CUTTER FOR IMPIX-C 14.5 x 16 x 8 & 9mm
• 03613720225355: IMPIX-C SUPPORT
• 03613720225348: HANDLE FOR DISTRACTOR AND CUTTER
• 03613720225102: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 8mm
• 03613720225096: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 7mm
• 03613720225089: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 6mm
• 03613720225072: DISTRACTOR FOR IMPIX-C 14.5 x 16 x 5mm
• 03613720225065: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 7mm
• 03613720225058: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 6 mm
• 03613720225041: DISTRACTOR FOR IMPIX-C 12.5 x 14 x 5 mm
• 03613720224990: GRAFT COMPACTOR FOR IMPIX-C 14.5mm x 16mm
• 03613720224983: GRAFT COMPACTOR FOR IMPIX-C 12.5mm x 14mm
• 03613720224976: CUTTER FOR IMPIX-C 14.5mm x 16mm
• 03613720224969: CUTTER FOR IMPIX-C 12.5mm x 14mm
• 03613720221340: 16mm PIN FOR CERVICAL DISTRACTOR, WITH NUT
• 03613720221326: 10mm PIN FOR CERVICAL DISTRACTOR, WITH NUT
• 03613720221302: 12mm PIN FOR CERVICAL DISTRACTOR, WITH NUT
• 03613720221289: 14mm PIN FOR CERVICAL DISTRACTOR, WITH NUT
• 03613720221265: LEFT CERVICAL DISTRACTOR
• 03613720221258: RIGHT CERVICAL DISTRACTOR