IMPIX 3D Print

GUDID 03613720270607

TLIF-B (C) 3DP 10x06°x33x10

MEDICREA INTERNATIONAL

Metallic spinal interbody fusion cage

• Primary Device ID: 03613720270607
• NIH Device Record Key: 11fbd233-8b96-4919-bc5b-a21f4c9bcb1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX 3D Print
• Version Model Number: B242C10063310
• 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	03613720270607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163595

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: 2020-02-24
• Device Publish Date: 2017-12-26

On-Brand Devices [IMPIX 3D Print]

• 03613720281627: Implant remover
• 03613720271635: Cage retriever
• 03613720267621: TLIF-O Holder, Long
• 03613720267614: TLIF-O Holder, Short
• 03613720267607: TLIF-B Holder, Long
• 03613720267911: Teardrop Curette, Angled
• 03613720267904: Teardrop Curette, Straight
• 03613720267898: Cup Curette, Straight #2 Serrated
• 03613720267881: Cup Curette, Straight #2
• 03613720267874: Cup Curette, Angled Up #4 Serrated
• 03613720267867: Cup Curette, Angled Right #4 Serrated
• 03613720267850: Cup Curette, Angled Left #4 Serrated
• 03613720267836: Cup Curette, Straight #4 Serrated
• 03613720267829: Cup Curette, Angled Up #4
• 03613720267812: Cup Curette, Angled Right #4
• 03613720267805: Cup Curette, Angled Left #4
• 03613720267782: Cup Curette, Straight #4
• 03613720273226: IB3D TB (E) 13 x 06° x 28 x 10 mm
• 03613720273202: IB3D TB (E) 12 x 06° x 28 x 10 mm
• 03613720273189: IB3D TB (E) 11 x 06° x 28 x 10 mm
• 03613720273165: IB3D TB (E) 10 x 06° x 28 x 10 mm
• 03613720273141: IB3D TB (E) 09 x 06° x 28 x 10 mm
• 03613720273127: IB3D TB (E) 08 x 06° x 28 x 10 mm
• 03613720272786: IB3D TO (C) 07 x 06° x 32 x 10
• 03613720272779: IB3D TO (C) 07 x 06° x 28 x 10
• 03613720272762: IB3D TO (C) 07 x 06° x 24 x 10
• 03613720272755: IB3D TO (C) 15 x 06° x 32 x 10
• 03613720272748: IB3D TO (C) 15 x 06° x 28 x 10
• 03613720272731: IB3D TO (C) 15 x 06° x 24 x 10
• 03613720272724: IB3D TO (C) 14 x 06° x 32 x 10
• 03613720272717: IB3D TO (C) 14 x 06° x 28 x 10
• 03613720272700: IB3D TO (C) 14 x 06° x 24 x 10
• 03613720272694: IB3D TO (C) 13 x 06° x 32 x 10
• 03613720272687: IB3D TO (C) 13 x 06° x 28 x 10
• 03613720272670: IB3D TO (C) 13 x 06° x 24 x 10
• 03613720272663: IB3D TO (C) 12 x 06° x 32 x 10
• 03613720272656: IB3D TO (C) 12 x 06° x 28 x 10
• 03613720272649: IB3D TO (C) 12 x 06° x 24 x 10
• 03613720272632: IB3D TO (C) 11 x 06° x 32 x 10
• 03613720272625: IB3D TO (C) 11 x 06° x 28 x 10
• 03613720272618: IB3D TO (C) 11 x 06° x 24 x 10
• 03613720272601: IB3D TO (C) 10 x 06° x 32 x 10
• 03613720272595: IB3D TO (C) 10 x 06° x 28 x 10
• 03613720272588: IB3D TO (C) 10 x 06° x 24 x 10
• 03613720272571: IB3D TO (C) 09 x 06° x 32 x 10
• 03613720272564: IB3D TO (C) 09 x 06° x 28 x 10
• 03613720272557: IB3D TO (C) 09 x 06° x 24 x 10
• 03613720272540: IB3D TO (C) 08 x 06° x 32 x 10
• 03613720272533: IB3D TO (C) 08 x 06° x 24 x 10
• 03613720272526: IB3D TO (C) 08 x 06° x 28 x 10