Catalog Number

-

Brand Name

JosNoe Medical Inc

Version/Model Number

JNM-LG01

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"

Yes

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

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Public Device Record Key

d4dfa606-e983-4069-b26c-198edcf90e0b

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

00850003294094

Quantity per Package

15

Contains DI Package

00850003294087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box