PullUp Probe Storage Covers - PROTEK MEDICAL PRODUCTS, INC.

Duns Number:965417181

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More Product Details

Catalog Number

-

Brand Name

PullUp Probe Storage Covers

Version/Model Number

1164

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

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

K970885,K970885

Product Code Details

Product Code

MMP

Product Code Name

Cover, Barrier, Protective

Device Record Status

Public Device Record Key

5b07d8fd-3459-4cc0-b495-e26afe4af0ff

Public Version Date

May 17, 2021

Public Version Number

4

DI Record Publish Date

October 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROTEK MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 451