KLS E-Coupling Adapter

GUDID 00856482008467

PRO-DEX, INC.

Surgical power tool adaptor
Primary Device ID00856482008467
NIH Device Record Key749485f0-a685-4ade-a55e-6ac46d450220
Commercial Distribution StatusIn Commercial Distribution
Brand NameKLS E-Coupling Adapter
Version Model NumberPDEC-1000-2
Company DUNS849370358
Company NamePRO-DEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100856482008467 [Primary]

FDA Product Code

GEYMotor, Surgical Instrument, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


[00856482008467]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-31
Device Publish Date2023-05-23

On-Brand Devices [KLS E-Coupling Adapter]

00856482008016PDEC-1000-3
00856482008467PDEC-1000-2

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