Slush Drape

GUDID 10848340006545

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 ID10848340006545
NIH Device Record Key6dcf7202-243f-439d-a33a-3236925c1596
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlush Drape
Version Model Number40-SD100
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
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS100848340006548 [Primary]
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution
GS110848340006545 [Package]
Contains: 00848340006548
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified
JAASystem, x-ray, fluoroscopic, image-intensified

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


[10848340006545]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by ADVANCE MEDICAL DESIGNS, INC.

10848340006545 - Slush Drape2020-06-17Disposable Equipment Cover
10848340006545 - Slush Drape2020-06-17 Disposable Equipment Cover
10848340015424 - Snap Kover2020-06-12 Disposable Equipment Cover
10848340013055 - Drape Sheet2020-06-08 Disposable Equipment Cover
10848340015400 - Drape Sheet2020-06-08 Disposable Equipment Cover
10848340000178 - UNBRANDED2020-05-22 Snap Kover
10848340000185 - UNBRANDED2020-05-22 Snap Kover
10848340001960 - UNBRANDED2020-05-22 Knob Cover
10848340002301 - Custom Snap Kover2020-05-22 Disposable Equipment Cover

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