Drape Sheet

GUDID 10848340015400

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile
Primary Device ID10848340015400
NIH Device Record Key2f6cb5db-5cb9-4707-a289-e4f4293edf20
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrape Sheet
Version Model NumberSYN-0796
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848340015403 [Primary]
GS110848340015400 [Package]
Contains: 00848340015403
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

[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


[10848340015400]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

On-Brand Devices [Drape Sheet]

10848340015400Disposable Equipment Cover
10848340013055Disposable Equipment Cover
10848340020329Tape on 1 side

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