Slush Drape

GUDID 10848340006545

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

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]
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

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


[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


[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.

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10848340015530 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340016834 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340016858 - Rolled Probe Cover2024-04-24 Disposable Equipment Cover
10848340015547 - Rolled Probe Cover2024-04-23 Disposable Equipment Cover
10848340012089 - Sterile Elastic Bands2024-04-22 Sterile Elastic Bands
10848340015486 - C-Arm Pack2024-04-22 Disposable Equipment Cover

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