Catalog Number

ICM-000-0600

Brand Name

Speculum Tubing

Version/Model Number

ICM-000-0600

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

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

9d455ced-ef49-41c5-8f40-5408c1edab7d

Public Version Date

November 12, 2020

Public Version Number

1

DI Record Publish Date

November 04, 2020

Package DI Number

00817688022947

Quantity per Package

25

Contains DI Package

00817688022930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-