FDA UDI In Commercial Distribution 🇺🇸 United States

Bella Turbo 25 Handpiece

DI: 00850055552173 · Model: NP253966D · Inbella Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Bella Turbo 25 Handpiece
Primary DI
00850055552173
Version / Model
NP253966D
Company Name
Inbella Medical Inc
Labeler DUNS
243330492
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-31
Public Version
1
Public Version Date
2026-04-08
Public Version Status
New
Public Device Record Key
3b2810ce-143b-415e-adc1-5ec665e0dd0e

Device Description

Bella Turbo 25 Handpiece

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
35156 Percutaneous radio-frequency ablation system generator

Identifiers

Type ID
Primary 00850055552173

Premarket Submissions

Submission Number Supplement Number
K243737 000
K251435 000