Table Cover - Back Stand Table Cover 44" x 76" (111cm x 193cm) - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Back Stand Table Cover 44" x 76" (111cm x 193cm)

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More Product Details

Catalog Number

396348

Brand Name

Table Cover

Version/Model Number

396348

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Device Record Status

Public Device Record Key

d40f9daa-9f36-4850-ab42-1d96b80523d5

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Additional Identifiers

Package DI Number

20886333212693

Quantity per Package

10

Contains DI Package

00886333212699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205