Vein Pick - Vein Pick - Oscor Inc.

Duns Number:101835833

Device Description: Vein Pick

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More Product Details

Catalog Number

VP52Y

Brand Name

Vein Pick

Version/Model Number

VP52Y

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K024053,K024053

Product Code Details

Product Code

DTB

Product Code Name

permanent pacemaker Electrode

Device Record Status

Public Device Record Key

5b2097e5-997b-4036-b1d7-e99c563862a1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSCOR INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 592
3 A medical device with high risk that requires premarket approval 16