Microscope Kover

GUDID 10848340009874

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use
Primary Device ID10848340009874
NIH Device Record Keyf6153ee9-8025-41af-ae77-3a8e251cc53c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroscope Kover
Version Model NumberMK971NS
Company DUNS130785884
Company NameADVANCE MEDICAL DESIGNS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340009877 [Primary]
GS110848340009874 [Package]
Contains: 00848340009877
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

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