AVANOS - PROBLOC* II Insulated Regional Block Needle with - Avanos Medical, Inc.

Duns Number:079375431

Device Description: PROBLOC* II Insulated Regional Block Needle with Injection Set

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More Product Details

Catalog Number

HN2-80

Brand Name

AVANOS

Version/Model Number

39202

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)

-

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

80cd468e-e219-4ad8-b218-352bab467eb4

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

July 03, 2020

Additional Identifiers

Package DI Number

10193494392021

Quantity per Package

10

Contains DI Package

00193494392024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221