FDA UDI In Commercial Distribution 🇺🇸 United States

BTL-585

DI: B108585POMUS00 · Model: BTL-585 · BTL INDUSTRIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BTL-585
Primary DI
B108585POMUS00
Version / Model
BTL-585
Company Name
BTL INDUSTRIES LIMITED
Labeler DUNS
733532951
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-01
Public Version
2
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
fe7b67a2-7358-4ba2-ac4a-86aca268ee33

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

GMDN Terms

Code Name
11490 Electrosurgical system generator

Identifiers

Type ID
Primary B108585POMUS00