NA - Perimeter Cover 42" x 80" NYN H&R-1p - CARILEX MEDICAL, INC.

Duns Number:658863238

Device Description: Perimeter Cover 42" x 80" NYN H&R-1p

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

S2503-A050

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

4ddf4215-2639-4575-b4c9-584f245f5051

Public Version Date

July 06, 2018

Public Version Number

1

DI Record Publish Date

June 05, 2018

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