EIT ALIF Paddle Distractor

GUDID 04260397082195

Paddle Distractor, H 18mm

EIT Emerging Implant Technologies GmbH

Orthopaedic surgical distractor, internal
Primary Device ID04260397082195
NIH Device Record Keye64c62de-a73c-4fcf-a54d-29996cb54565
Commercial Distribution StatusIn Commercial Distribution
Brand NameEIT ALIF Paddle Distractor
Version Model NumberAET10218
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
GS104260397082195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260397082195]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-09

On-Brand Devices [EIT ALIF Paddle Distractor]

04260557774762Paddle Distractor, H20mm
04260557774755Paddle Distractor, H19mm
04260557774748Paddle Distractor, H 17mm
04260557774731Paddle Distractor, H 15mm
04260557774724Paddle Distractor, H 13mm
04260557774717Paddle Distractor, H 11mm
04260557774700Paddle Distractor, H 9mm
04260397082195Paddle Distractor, H 18mm
04260397082188Paddle Distractor, H 16mm
04260397082171Paddle Distractor, H 14mm
04260397082164Paddle Distractor, H 12mm
04260397082157Paddle Distractor, H 10mm
04260397082140Paddle Distractor, H 8mm

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