TRIPOD Heart Stabilizer-Nylon Fastract - Heart Stabilizer, Nylon Textured Feet - KDL MEDICAL, INC.

Duns Number:791048924

Device Description: Heart Stabilizer, Nylon Textured Feet

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More Product Details

Catalog Number

-

Brand Name

TRIPOD Heart Stabilizer-Nylon Fastract

Version/Model Number

STB-30C4S

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

-

Product Code Details

Product Code

MWS

Product Code Name

Stabilizer,Heart

Device Record Status

Public Device Record Key

153e8b29-87e6-4e27-966b-1372a30d1aa8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KDL MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 42