Tex-Care Medical - 4X48 DP POLY - Flynt/Amtex, Inc.

Duns Number:038730060

Device Description: 4X48 DP POLY

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More Product Details

Catalog Number

-

Brand Name

Tex-Care Medical

Version/Model Number

91322-448

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IPM

Product Code Name

Cover, Limb

Device Record Status

Public Device Record Key

186f3f07-57ee-4063-8041-b2fcd2a99a81

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLYNT/AMTEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 188
2 A medical device with a moderate to high risk that requires special controls. 40