WATTSON - WattsonGuidewire,280cm - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: WattsonGuidewire,280cm

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More Product Details

Catalog Number

2250

Brand Name

WATTSON

Version/Model Number

IPN914275

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

-

Product Code Details

Product Code

DQX

Product Code Name

Wire, guide, catheter

Device Record Status

Public Device Record Key

2a1ea03a-0bea-492b-9a9d-8a2d2b2c4be1

Public Version Date

February 04, 2020

Public Version Number

1

DI Record Publish Date

January 27, 2020

Additional Identifiers

Package DI Number

20841156106499

Quantity per Package

1

Contains DI Package

10841156106492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26