Catalog Number

C-000.32.706

Brand Name

HIGH RESOLUTION PRISMATIC LOUPE OPTICS

Version/Model Number

C-000.32.706

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2021

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

-

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

FSP

Product Code Name

LOUPE, DIAGNOSTIC/SURGICAL

Public Device Record Key

39ffc783-e8b8-4c58-9a70-9529d88aabd3

Public Version Date

January 05, 2021

Public Version Number

2

DI Record Publish Date

September 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-