Skytron Enzymatic cleaner J5-010-02

GUDID 10841736110499

Detergent, Enzymatic instrument, 5 gallon container with 70mm cap

SKYTRON LLC

Medical device cleaning agent
Primary Device ID10841736110499
NIH Device Record Key2b2e0dd3-c055-4ebe-8d75-f57bff28d2b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkytron Enzymatic cleaner
Version Model NumberJ5-010-02
Catalog NumberJ5-010-02
Company DUNS078375583
Company NameSKYTRON LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us
Phone+1(800)759-8766
Emailinfo@skytron.us

Device Identifiers

Device Issuing AgencyDevice ID
GS110841736110499 [Primary]

FDA Product Code

MECDisinfector, medical devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-04
Device Publish Date2016-12-21

Devices Manufactured by SKYTRON LLC

10841736124304 - F101 SERIES MOUNT WITH 1 LF ARM2025-05-19 F101 SERIES MOUNT WITH 1 LF ARM
10841736124311 - F102 SERIES MOUNT WITH 2 LF ARMS2025-05-19 F102 SERIES MOUNT WITH 2 LF ARMS
10841736114985 - Skytron DoVera Positioning Handle2024-09-11 Skytron DoVera Positioning Handle (Camera Cover Handle)
10841736124151 - Center Focus Handle2024-06-20 Center Focus Handle with Intensity Control for Lumos Series, black
10841736124168 - Camera Cover2024-06-20 Sterilizable Camera Cover with intensity control for Lumos Series, black
10841736123406 - Sterling M10002024-04-10 M1000 S208E, Single door, Electric, 208V
10841736123413 - Sterling M10002024-04-10 M1000 S480E, Single door, Electric, 480V
10841736123420 - Sterling M10002024-04-10 M1000 S208S, Single door, Steam, 208V

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