Light Handle Cover

GUDID 10848340014618

Disposable Light Handle Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile
Primary Device ID10848340014618
NIH Device Record Keyefd1cbea-1d17-4028-8f30-95fc9f4d75fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight Handle Cover
Version Model NumberCLK03
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
GS100848340014611 [Primary]
GS110848340014618 [Package]
Contains: 00848340014611
Package: [250 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 Date2022-11-08
Device Publish Date2022-10-31

On-Brand Devices [Light Handle Cover]

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