FDA UDI In Commercial Distribution 🇺🇸 United States

BTL-785L

DI: B108785PO6MUS10 · Model: BTL-785L · BTL INDUSTRIES LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BTL-785L
Primary DI
B108785PO6MUS10
Version / Model
BTL-785L
Company Name
BTL INDUSTRIES LIMITED
Labeler DUNS
733532951
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-28
Public Version
1
Public Version Date
2023-07-06
Public Version Status
New
Public Device Record Key
c6eb99ab-9b70-48dd-8077-f507275e7bac

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
40785 Multi-modality hyperthermia system

Identifiers

Type ID
Primary B108785PO6MUS10