ARROW - SureBlock(TM) Spinal Anesthesia Set with Sharps - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: SureBlock(TM) Spinal Anesthesia Set with Sharps Safety Features

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More Product Details

Catalog Number

ASA-27090-SS

Brand Name

ARROW

Version/Model Number

IPN040091

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

K911260,K911260

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

b500324c-39b1-4347-844d-57d552a13333

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902059964

Quantity per Package

5

Contains DI Package

00801902059963

Package Discontinue Date

October 30, 2018

Package Status

Not 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