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

Duns Number:002348191

Device Description: SureBlock(TM) Spinal Anesthesia Set

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More Product Details

Catalog Number

ASA-22090-S

Brand Name

ARROW

Version/Model Number

IPN040064

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

-

Product Code Details

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Record Status

Public Device Record Key

8e989682-5b04-4784-a71e-a921beeb7d25

Public Version Date

November 14, 2019

Public Version Number

3

DI Record Publish Date

October 15, 2018

Additional Identifiers

Package DI Number

20801902074212

Quantity per Package

5

Contains DI Package

10801902074215

Package Discontinue Date

November 05, 2019

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