ARROW - SureBlock(TM) Spinal Anesthesia Kit with 0.75% - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: SureBlock(TM) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ASA-25090-SB

Brand Name

ARROW

Version/Model Number

IPN045632

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

K911260,K911260

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

1474ea7a-4188-4545-9aa4-210ad8193746

Public Version Date

July 22, 2022

Public Version Number

5

DI Record Publish Date

October 15, 2018

Additional Identifiers

Package DI Number

40801902074193

Quantity per Package

5

Contains DI Package

50801902074190

Package Discontinue Date

July 21, 2022

Package Status

Not 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