NA - Relief Cushion C-Set 16 x 20" TDX H&R - CARILEX MEDICAL, INC.

Duns Number:658863238

Device Description: Relief Cushion C-Set 16 x 20" TDX H&R

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

S2204-7010

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

-

Prescription Use (Rx)

-

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

KIC

Product Code Name

Cushion, Flotation

Device Record Status

Public Device Record Key

6552c64d-4378-486d-aed1-3d3c8477c525

Public Version Date

March 30, 2020

Public Version Number

3

DI Record Publish Date

March 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARILEX MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 144