ARROW - Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Set - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Arrow-Clarke(TM) Pleura-Seal(R) Thoracentesis Set

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More Product Details

Catalog Number

CS-01000

Brand Name

ARROW

Version/Model Number

IPN033012

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)

Yes

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

K870572,K870572

Product Code Details

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Device Record Status

Public Device Record Key

1ec33298-9a7a-4d3d-9bc5-91f35c576dce

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902099588

Quantity per Package

10

Contains DI Package

00801902099587

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