EIT PLIF Iserter

GUDID 04260557776124

T-Handle Inserter

EIT Emerging Implant Technologies GmbH

Orthopaedic implant inserter/extractor, reusable
Primary Device ID04260557776124
NIH Device Record Keyc0fc0efa-a902-4404-ab2f-3838f20ec709
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIT PLIF Iserter
Version Model NumberPET30103
Company DUNS313088331
Company NameEIT Emerging Implant Technologies GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260557776124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260557776124]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2018-09-21

Devices Manufactured by EIT Emerging Implant Technologies GmbH

04260557770009 - EIT CIF cage2020-02-24 EIT CIF cage, H 5mm, 0°, S
04260557770016 - EIT CIF cage2020-02-24 EIT CIF cage, H 5mm, 0°, S
04260557770023 - EIT CIF cage2020-02-24 EIT CIF cage, H 6mm, 0°, S
04260557770030 - EIT CIF cage2020-02-24 EIT CIF cage, H 7mm, 0°, S
04260557770047 - EIT CIF cage2020-02-24 EIT CIF cage, H 8mm, 0°, S
04260557770054 - EIT CIF cage2020-02-24 EIT CIF cage, H 9mm, 0°, S
04260557770061 - EIT CIF cage2020-02-24 EIT CIF cage, H 10mm, 0°, S
04260557770078 - EIT CIF cage2020-02-24 EIT CIF cage, H 11mm, 0°, S

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