FDA UDI In Commercial Distribution 🇺🇸 United States

RadiOpaque Radiofrequency Cannula

DI: 00193493986422 · Model: PMF21-100-5 · Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
RadiOpaque Radiofrequency Cannula
Primary DI
00193493986422
Version / Model
PMF21-100-5
Catalog Number
PMF21-100-5
Company Name
Avanos Medical, Inc.
Labeler DUNS
079375431
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-25
Public Version
4
Public Version Date
2023-06-22
Public Version Status
Update
Public Device Record Key
8a67f3ff-ac43-4ce7-905c-67329e255190

Device Description

Straight RF Cannula, Radiopaque Marker

Device Characteristics

Single Use
Yes
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
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
58739 Percutaneous radio-frequency ablation probe cannula, single-use

Identifiers

Type ID
Package 10193493986429
Primary 00193493986422
Package 20193493986426

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K972846 000