FDA UDI In Commercial Distribution 🇺🇸 United States

COOLIEF* Cooled Radiofrequency Sterile Tube Kit

DI: 00193493096930 · Model: 09693 · Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
COOLIEF* Cooled Radiofrequency Sterile Tube Kit
Primary DI
00193493096930
Version / Model
09693
Catalog Number
TDA-TBK-1
Company Name
Avanos Medical, Inc.
Labeler DUNS
079375431
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-07-01
Public Version
2
Public Version Date
2023-06-22
Public Version Status
Update
Public Device Record Key
8b366166-5701-40c6-a86d-3455cc6065c8

Device Description

COOLIEF* Cooled Radiofrequency Sterile Tube Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GXI PROBE, RADIOFREQUENCY LESION

GMDN Terms

Code Name
44772 Cardiac ablation system irrigation tubing set

Identifiers

Type ID
Primary 00193493096930

Customer Contacts