Halyard - FOAM POSITIONER PADS/OVERLAYS UTILITY PAD - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: FOAM POSITIONER PADS/OVERLAYS UTILITY PAD CONVOLUTED POLYURETHANE FOAM BLUE DISPOSABLE NOT FOAM POSITIONER PADS/OVERLAYS UTILITY PAD CONVOLUTED POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD

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More Product Details

Catalog Number

-

Brand Name

Halyard

Version/Model Number

48740

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"

Yes

For Single-Use

Yes

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

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Device Record Status

Public Device Record Key

7c853fbd-85b4-40a8-b304-eac5322b055c

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

40885632373306

Quantity per Package

12

Contains DI Package

20885632373302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1