EIT TLIF Opening Knob

GUDID 04260397087640

Opening Knob

EIT Emerging Implant Technologies GmbH

Surgical instrument handle, non-torque-limiting
Primary Device ID04260397087640
NIH Device Record Key97c17a65-2c67-4506-a01b-12a31344ce6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIT TLIF Opening Knob
Version Model NumberTET40100
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
GS104260397087640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260397087640]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2018-01-11

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