IMPIX MANTA B20121796

GUDID 03613720230786

IMPIX-MANTA 17x14x9mm at 6°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID03613720230786
NIH Device Record Key660dafb3-a616-450c-b83b-9058867dc4da
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPIX MANTA
Version Model NumberB20121796
Catalog NumberB20121796
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720230786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

[03613720230786]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-08-05
Device Publish Date2015-10-23

On-Brand Devices [IMPIX MANTA]

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