TB - Oscor Inc.

Duns Number:101835833

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More Product Details

Catalog Number

-

Brand Name

TB

Version/Model Number

020010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

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

K861403

Product Code Details

Product Code

LDF

Product Code Name

Electrode, Pacemaker, Temporary

Device Record Status

Public Device Record Key

4fbd62c8-77df-449a-bbb3-101d311b2445

Public Version Date

July 24, 2020

Public Version Number

5

DI Record Publish Date

October 16, 2015

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