IMPIX-ALIF S/A B15231412

GUDID 03613720228073

IMPIX-ALIF S/A Small 14mm x 12°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage
Primary Device ID03613720228073
NIH Device Record Keye7c6149f-29dd-445f-9a98-fb25711e3aa5
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPIX-ALIF S/A
Version Model NumberB15231412
Catalog NumberB15231412
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
DM Exempttrue
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
GS103613720228073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-08-06
Device Publish Date2017-01-27

On-Brand Devices [IMPIX-ALIF S/A]

03613720266860DETACHABLE HOLDER
03613720266853STRAIGHT SCREW REMOVER
03613720228202IMPIX-ALIF S/A Medium 14mm x 12°
03613720228196IMPIX-ALIF S/A Medium 14mm x 9°
03613720228189IMPIX-ALIF S/A Medium 12mm x 12°
03613720228172IMPIX-ALIF S/A Medium 12mm x 9°
03613720228165IMPIX-ALIF S/A Medium 10mm x 15°
03613720228158IMPIX-ALIF S/A Medium 10mm x 12°
03613720228141IMPIX-ALIF S/A Medium 10mm x 9°
03613720228073IMPIX-ALIF S/A Small 14mm x 12°
03613720228066IMPIX-ALIF S/A Small 14mm x 9°
03613720228059IMPIX-ALIF S/A Small 12mm x 12°
03613720228042IMPIX-ALIF S/A Small 12mm x 9°
03613720228035IMPIX-ALIF S/A Small 10mm x 15° °
03613720228028IMPIX-ALIF S/A Small 10mm x 12°
03613720228011IMPIX-ALIF S/A Small 10mm x 9°
03613720219187IMPIX ALIF S/A TRIAL MEDIUM 20mm - 15°
03613720219170IMPIX ALIF S/A TRIAL MEDIUM 20mm - 12°
03613720219163IMPIX ALIF S/A TRIAL MEDIUM 20mm - 9°
03613720219156IMPIX ALIF S/A TRIAL MEDIUM 20mm - 6°
03613720219149IMPIX ALIF S/A TRIAL MEDIUM 20mm -3°
03613720219132IMPIX ALIF S/A TRIAL MEDIUM 20mm - 0°
03613720219125IMPIX ALIF S/A TRIAL MEDIUM 18mm - 15°
03613720219118IMPIX ALIF S/A TRIAL MEDIUM 18mm - 12°
03613720219101IMPIX ALIF S/A TRIAL MEDIUM 18mm - 9°
03613720219095IMPIX ALIF S/A TRIAL MEDIUM 18mm - 6°
03613720219088IMPIX ALIF S/A TRIAL MEDIUM 18mm -3°
03613720219071IMPIX ALIF S/A TRIAL MEDIUM 18mm - 0°
03613720219064IMPIX ALIF S/A TRIAL MEDIUM 16mm -15°
03613720219057IMPIX ALIF S/A TRIAL MEDIUM 16mm - 12°
03613720219040IMPIX ALIF S/A TRIAL MEDIUM 16mm - 9°
03613720219033IMPIX ALIF S/A TRIAL MEDIUM 16mm - 6°
03613720219026IMPIX ALIF S/A TRIAL MEDIUM 16mm -3°
03613720219019IMPIX ALIF S/A TRIAL MEDIUM 16mm - 0°
03613720218975IMPIX ALIF S/A TRIAL MEDIUM 14mm - 6°
03613720218968IMPIX ALIF S/A TRIAL MEDIUM 40mm -3°
03613720218944IMPIX ALIF S/A TRIAL MEDIUM 12mm -15°
03613720218937IMPIX ALIF S/A TRIAL MEDIUM 12mm - 12°
03613720218920IMPIX ALIF S/A TRIAL MEDIUM 12mm - 9°
03613720270911INSTRUMENTS FOR ALIF S/A TRAY 2
03613720218883IMPIX ALIF S/A TRIAL MEDIUM 10mm -15°
03613720218777IMPIX ALIF S/A TRIAL LARGE 20mm - 3°
03613720218630IMPIX ALIF S/A TRIAL LARGE 14mm - 15°
03613720218005IMPIX ALIF S/A TRIAL SMALL 18mm - 3°
03613720217985IMPIX-ALIF S/A TRIAL SMALL 16mm x 15°
03613720217855IMPIX ALIF S/A TRIAL SMALL 12mm - 12°
03613720217565IMPIX ALIF S/A RASP SMALL
03613720240921IMPACTION SOCKET -LARGE- 16 to 20 mm WITHOUT END STOP
03613720240884IMPACTION SOCKET -SMALL- 16 to 20 mm WITHOUT END STOP
03613720217671SELF RETAINING SCREWDRIVER WITH STOP
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