MediChoice - Coat Laboratory Non-Woven Three-Pocket Knit Cuff - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Coat Laboratory Non-Woven Three-Pocket Knit Cuff 5 Snap-Front Standard 2X Large Sturdy Pol Coat Laboratory Non-Woven Three-Pocket Knit Cuff 5 Snap-Front Standard 2X Large Sturdy Polypropylene White Disposable Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

3304XX

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

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Device Record Status

Public Device Record Key

0015505c-f51e-4d27-968e-7cd6a1f46df2

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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