Catalog Number

210-100

Brand Name

Aveta Smol Disposable Resecting Device, 2.9 mm

Version/Model Number

210-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K190372,K190372

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

db58a026-0fdf-40ab-8a91-c301a7f4de86

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

00850006759347

Quantity per Package

3

Contains DI Package

00850006759309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shelf carton