ARROW - Percutaneous Cavity Drainage Catheterization - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Percutaneous Cavity Drainage Catheterization Seldinger Insertion Technique

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More Product Details

Catalog Number

AK-01600

Brand Name

ARROW

Version/Model Number

IPN036836

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K895516,K895516

Product Code Details

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Device Record Status

Public Device Record Key

5369a25b-6dde-4858-91ff-1e59d9486c11

Public Version Date

March 29, 2022

Public Version Number

5

DI Record Publish Date

March 07, 2018

Additional Identifiers

Package DI Number

60801902120153

Quantity per Package

5

Contains DI Package

50801902120156

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