GUIDELINER - GuideLiner V3 6F - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: GuideLiner V3 6F

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More Product Details

Catalog Number

5571

Brand Name

GUIDELINER

Version/Model Number

IPN915841

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"

Yes

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

DQY

Product Code Name

Catheter, percutaneous

Device Record Status

Public Device Record Key

519c2128-566e-4952-ab24-30e5164fba9e

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2021

Additional Identifiers

Package DI Number

20841156106567

Quantity per Package

1

Contains DI Package

10841156106560

Package Discontinue Date

-

Package Status

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