DIATHERMY BIPOLAR CABLE - This re-usable device is an accessory for ZEISS - Carl Zeiss Meditec AG

Duns Number:342228620

Device Description: This re-usable device is an accessory for ZEISS phaco systems. It has been designed to con This re-usable device is an accessory for ZEISS phaco systems. It has been designed to connect the diathermy handpieces to the main device during human eye surgery.

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More Product Details

Catalog Number

-

Brand Name

DIATHERMY BIPOLAR CABLE

Version/Model Number

303060-0250-000

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)

Yes

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

HQR

Product Code Name

Apparatus, Cautery, Radiofrequency, Ac-Powered

Device Record Status

Public Device Record Key

385d90d6-30ed-4071-bbf5-2652ac4249e1

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

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