FDA UDI In Commercial Distribution 🇺🇸 United States

DIATHERMY BIPOLAR CABLE

DI: 04049539100498 · Model: 303060-0250-000 · Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
DIATHERMY BIPOLAR CABLE
Primary DI
04049539100498
Version / Model
303060-0250-000
Company Name
Carl Zeiss Meditec AG
Labeler DUNS
342228620
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-04-25
Public Version
1
Public Version Date
2022-05-03
Public Version Status
New
Public Device Record Key
385d90d6-30ed-4071-bbf5-2652ac4249e1

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 04049539100498