CANNULA 7MM TEFLON STERILE - 1/packaging - CANNULA 7MM TEFLON STERILE - 1/packaging - WATERS MEDICAL SYSTEMS, LLC

Duns Number:556957871

Device Description: CANNULA 7MM TEFLON STERILE - 1/packaging

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More Product Details

Catalog Number

3910141.007

Brand Name

CANNULA 7MM TEFLON STERILE - 1/packaging

Version/Model Number

CANNULA 7MM TEFLON STERILE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K971571

Product Code Details

Product Code

KDN

Product Code Name

System, Perfusion, Kidney

Device Record Status

Public Device Record Key

3d69be5c-6531-4042-9645-bd64d4834405

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

February 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATERS MEDICAL SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53