IMPIX MANTA B20121973

GUDID 03613720230816

IMPIX-MANTA 19.5x14x7mm at 3°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720230816
• NIH Device Record Key: b85d1afc-f111-4fb2-9e76-12a3914d0d6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX MANTA
• Version Model Number: B20121973
• Catalog Number: B20121973
• 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	03613720230816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100484

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

[03613720230816]

Moist Heat or Steam Sterilization

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 MANTA]

• 03613720233749: IMPIX-MANTA ON HOLDER LARGE 8mm - 3°
• 03613720233718: IMPIX-MANTA ON HOLDER LARGE 7mm - 3°
• 03613720233688: IMPIX-MANTA ON HOLDER LARGE 6mm - 3°
• 03613720233657: IMPIX-MANTA ON HOLDER LARGE 5mm - 3°
• 03613720233558: IMPIX-MANTA ON HOLDER MEDIUM 8mm - 3°
• 03613720233527: IMPIX-MANTA ON HOLDER MEDIUM 7mm - 3°
• 03613720233497: IMPIX-MANTA ON HOLDER MEDIUM 6mm - 3°
• 03613720233466: IMPIX-MANTA ON HOLDER MEDIUM 5mm - 3°
• 03613720233367: IMPIX-MANTA ON HOLDER SMALL 8mm - 3°
• 03613720233336: IMPIX-MANTA ON HOLDER SMALL 7mm - 3°
• 03613720233305: IMPIX-MANTA ON HOLDER SMALL 6mm - 3°
• 03613720233275: IMPIX-MANTA ON HOLDER SMALL 5mm - 3°
• 03613720231004: IMPIX-MANTA 22x14x9mm at 6°
• 03613720230991: IMPIX-MANTA 22x14x9mm at 3°
• 03613720230984: IMPIX-MANTA 22x14x9mm at 0°
• 03613720230977: IMPIX-MANTA 22x14x8mm at 6°
• 03613720230960: IMPIX-MANTA 22x14x8mm at 3°
• 03613720230953: IMPIX-MANTA 22x14x8mm at 0°
• 03613720230946: IMPIX-MANTA 22x14x7mm at 6°
• 03613720230939: IMPIX-MANTA 22x14x7mm at 3°
• 03613720230922: IMPIX-MANTA 22x14x7mm at 0°
• 03613720230915: IMPIX-MANTA 22x14x6mm at 6°
• 03613720230908: IMPIX-MANTA 22x14x6mm at 3°
• 03613720230892: IMPIX-MANTA 22x14x6mm at 0°
• 03613720230885: IMPIX-MANTA 22x14x5mm at 6°
• 03613720230878: IMPIX-MANTA 22x14x5mm at 3°
• 03613720230861: IMPIX-MANTA 22x14x5mm at 0°
• 03613720230854: IMPIX-MANTA 22x14x10mm at 6°
• 03613720230847: IMPIX-MANTA 22x14x10mm at 3°
• 03613720230830: IMPIX-MANTA 22x14x10mm at 0°
• 03613720230823: IMPIX-MANTA 19.5x14x8mm at 3°
• 03613720230816: IMPIX-MANTA 19.5x14x7mm at 3°
• 03613720230809: IMPIX-MANTA 19.5x14x6mm at 3°
• 03613720230793: IMPIX-MANTA 19.5x14x5mm at 3°
• 03613720230786: IMPIX-MANTA 17x14x9mm at 6°
• 03613720230779: IMPIX-MANTA 17x14x9mm at 3°
• 03613720230762: IMPIX-MANTA 17x14x9mm at 0°
• 03613720230755: IMPIX-MANTA 17x14x8mm at 6°
• 03613720230748: IMPIX-MANTA 17x14x8mm at 3°
• 03613720230731: IMPIX-MANTA 17x14x8mm at 0°
• 03613720230724: IMPIX-MANTA 17x14x7mm at 6°
• 03613720230717: IMPIX-MANTA 17x14x7mm at 3°
• 03613720230700: IMPIX-MANTA 17x14x7mm at 0°
• 03613720230694: IMPIX-MANTA 17x14x6mm at 6°
• 03613720230687: IMPIX-MANTA 17x14x6mm at 3°
• 03613720230670: IMPIX-MANTA 17x14x6mm at 0°
• 03613720230663: IMPIX-MANTA 17x14x5mm at 6°
• 03613720230656: IMPIX-MANTA 17x14x5mm at 3°
• 03613720230649: IMPIX-MANTA 17x14x5mm at 0°
• 03613720230618: IMPIX-MANTA 17x14x10mm at 0°