OPMI® PENTERO® 900 - Carl Zeiss Meditec AG

Duns Number:342228620

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

OPMI® PENTERO® 900

Version/Model Number

302582-9902-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSO

Product Code Name

Microscope, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

a6010948-7280-4c1b-8b93-85efb27b5f89

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARL ZEISS MEDITEC AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 86
3 A medical device with high risk that requires premarket approval 1