Catalog Number

-

Brand Name

KMC OneShot Single Balloon Assembly, 8 Gauge, 10mm

Version/Model Number

KMCA-201-10

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

K113742

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

c17462b7-dd0a-420d-b6c9-72066100f1a2

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-