FDA UDI In Commercial Distribution 🇺🇸 United States

truSculpt iD Hands Free 40

DI: 00816722022462 · Model: truSculpt iD Hands Free 40 · CUTERA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
truSculpt iD Hands Free 40
Primary DI
00816722022462
Version / Model
truSculpt iD Hands Free 40
Company Name
CUTERA, INC.
Labeler DUNS
041071643
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-13
Public Version
1
Public Version Date
2019-01-14
Public Version Status
New
Public Device Record Key
a33721fe-5ec9-4df7-b041-261ef6e5e4f4

Device Description

truSculpt iD Hands Free 40 Handpiece

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
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
PBX Massager, Vacuum, Radio Frequency Induced Heat

GMDN Terms

Code Name
45214 Radio-frequency skin contouring system applicator, monopolar

Identifiers

Type ID
Primary 00816722022462