AVANOS - CRPA-17-150 AVNS,PROBE,PROBE,,-,1 - Avanos Medical, Inc.

Duns Number:079375431

Device Description: CRPA-17-150 AVNS,PROBE,PROBE,,-,1

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More Product Details

Catalog Number

CRPA-17-150

Brand Name

AVANOS

Version/Model Number

CRPA-17-150

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

-

Product Code Details

Product Code

GXI

Product Code Name

Probe, radiofrequency lesion

Device Record Status

Public Device Record Key

7190dcdc-6cd7-4b71-932b-8461d560acdb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 11, 2021

Additional Identifiers

Package DI Number

10193493478986

Quantity per Package

10

Contains DI Package

00193493478989

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