TAUT - WECKVISTA ACCESS BALLOON PORT 10MMX70MM - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: WECKVISTA ACCESS BALLOON PORT 10MMX70MM

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More Product Details

Catalog Number

410944

Brand Name

TAUT

Version/Model Number

IPN006635

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

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

21d87f59-c869-4c8d-b1a8-571e79f8d08c

Public Version Date

November 06, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

44026704559754

Quantity per Package

4

Contains DI Package

24026704559750

Package Discontinue Date

June 26, 2020

Package Status

Not in Commercial Distribution

Package Type

Box

"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