Custom Bag W/Cuff

GUDID 10848340020275

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use
Primary Device ID10848340020275
NIH Device Record Key84540747-cf62-4fc0-ba01-94564a8af2c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Bag W/Cuff
Version Model Number08-CC146
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
GS100848340020278 [Primary]
GS110848340020275 [Package]
Contains: 00848340020278
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

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

[10848340020275]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

Devices Manufactured by ADVANCE MEDICAL DESIGNS, INC.

10848340010481 - Mitaka Drape2024-04-25 Disposable Equipment Cover
10848340011464 - Mitaka Spy Elite2024-04-25 Disposable Equipment Cover
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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