ARROW - Percutaneous Sheath Introducer Set with Integral - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 7 Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters

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More Product Details

Catalog Number

SI-09880-SB

Brand Name

ARROW

Version/Model Number

IPN923926

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

K780532,K780532

Product Code Details

Product Code

DYB

Product Code Name

Introducer, catheter

Device Record Status

Public Device Record Key

6c1a7549-4c62-43ef-b726-6ea6a367227c

Public Version Date

May 10, 2022

Public Version Number

1

DI Record Publish Date

May 02, 2022

Additional Identifiers

Package DI Number

20801902207221

Quantity per Package

10

Contains DI Package

10801902207224

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