Tex-Care Medical - 4"X4YD SYN CAST PAD PKG - Flynt/Amtex, Inc.

Duns Number:038730060

Device Description: 4"X4YD SYN CAST PAD PKG

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More Product Details

Catalog Number

-

Brand Name

Tex-Care Medical

Version/Model Number

91857-404

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

LGF

Product Code Name

Component, Cast

Device Record Status

Public Device Record Key

9df5e596-ff61-427b-b43a-d56f61d4010b

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 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