EIT PLIF Inserter

GUDID 04260397088388

T-Handle Inserter

EIT Emerging Implant Technologies GmbH

Orthopaedic implant inserter/extractor, reusable
Primary Device ID04260397088388
NIH Device Record Key0f960bf6-2cee-495b-b0f1-09f88a7a1bfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIT PLIF Inserter
Version Model NumberPET30101
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
GS104260397088388 [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

[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


[04260397088388]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-04-23
Device Publish Date2018-01-05

On-Brand Devices [EIT PLIF Inserter]

04260397088388T-Handle Inserter
04260397088067Inserter Pin SH Connection
04260397088050Inserter S-Hammer Connection
04260397080832Inserter

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