EIT PLIF Trial a

GUDID 04260397087701

Trial, H: 16 mm, 8°, 30/9

EIT Emerging Implant Technologies GmbH

Spinal implant trial
Primary Device ID04260397087701
NIH Device Record Keyb28ff3b2-95bb-4af0-9bb8-a527bce9827d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIT PLIF Trial a
Version Model NumberPET81610
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
GS104260397087701 [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

[04260397087701]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-09-27

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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