Catalog Number

-

Brand Name

JosNoe Medical Inc

Version/Model Number

HF-7001S

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

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Public Device Record Key

ae291d38-9531-41be-9891-172d0897e181

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2019

Package DI Number

00850003294520

Quantity per Package

10

Contains DI Package

00850003294513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box