Catalog Number

LL0006

Brand Name

Urology Set

Version/Model Number

LL0006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172048,K172048

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

db6dfffa-8e72-442b-861b-6cc4c31034f6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2018

Package DI Number

20860936000369

Quantity per Package

10

Contains DI Package

00860936000365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box