Endoscopy Kit - Set Up

GUDID 00858276007502

Endoscopy Kit - Set Up

Micro-tech Usa

Endoscopy preparation kit
Primary Device ID00858276007502
NIH Device Record Key4f57fbc8-fd8d-4049-af84-b4018f31a00f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoscopy Kit - Set Up
Version Model NumberMDKT1A0003A
Company DUNS079873914
Company NameMicro-tech Usa
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858276007496 [Primary]
GS100858276007502 [Package]
Contains: 00858276007496
Package: Box [12 Units]
In Commercial Distribution
GS100858276007519 [Package]
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

KMJLubricant, Patient

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

Devices Manufactured by Micro-tech Usa

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10850025860861 - CO2 Source Tubing Adapter Fuji GW1002025-05-20 CO2 Source Tubing Adapter, Fuji GW100 CO2 Insufflator, Non-Sterile.
10850025860908 - CO2 Source Tubing Filter Adapter Olympus2025-05-20 CO2 Source Tubing Filter Adapter Olympus, Sterile, Single Day Use.
10858276007974 - CO2 Source Tubing Filter Olympus2025-05-20 CO2 Source Tubing Filter Olympus, Sterile, Single Day Use.
10858276007981 - Endoscopy Kit - Compliance+ FUJ5 Kit2025-05-20 Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use
10850025860809 - Scope Tip Protector2025-03-19 Distal Tip Protector Small
10850025860816 - Scope Tip Protector2025-03-19 Distal Tip Protector Large
00850025860437 - Irrigation Tubing Set2025-03-17 Irrigation Tubing Set

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