MedStream - SHOE COVERS STERILE 5PRS - MEDICAL SPECIALTIES DISTRIBUTORS, LLC

Duns Number:153608369

Device Description: SHOE COVERS STERILE 5PRS

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More Product Details

Catalog Number

MSPP-020088

Brand Name

MedStream

Version/Model Number

MSPP-020088

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

PXG

Product Code Name

Spill Kit

Device Record Status

Public Device Record Key

0647e28f-f177-474a-8602-9819eb3b0fa4

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 27, 2018

Additional Identifiers

Package DI Number

10842472106760

Quantity per Package

25

Contains DI Package

00842472106763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL SPECIALTIES DISTRIBUTORS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 202
2 A medical device with a moderate to high risk that requires special controls. 86