Micro Kover for Glass Lens

GUDID 10848340017176

Micro Kover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use
Primary Device ID10848340017176
NIH Device Record Key95513973-892c-4fcf-b389-4e06edba74e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro Kover for Glass Lens
Version Model Number09-GL904
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340017179 [Primary]
GS110848340017176 [Package]
Contains: 00848340017179
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

Ethylene Oxide


[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

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[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


[10848340017176]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-11
Device Publish Date2024-03-01

On-Brand Devices [Micro Kover for Glass Lens]

10848340017176Micro Kover
10848340020237Micro Kover
10848340020268Micro Kover
10848340020251Micro Kover
10848340010009Micro Kover

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