Catalog Number

INTVM-15

Brand Name

InterV

Version/Model Number

INTVM-15

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

K132620

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

47fb63af-9e7c-444d-ad3a-5816b1619a0f

Public Version Date

May 22, 2019

Public Version Number

1

DI Record Publish Date

May 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-