FDA UDI In Commercial Distribution 🇺🇸 United States

BTL Chair Applicator

DI: B108899AP2M3MUS00 · Model: 899-AP-M-3 · BTL INDUSTRIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BTL Chair Applicator
Primary DI
B108899AP2M3MUS00
Version / Model
899-AP-M-3
Company Name
BTL INDUSTRIES LIMITED
Labeler DUNS
733532951
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-07
Public Version
2
Public Version Date
2021-01-22
Public Version Status
Update
Public Device Record Key
40ceedb0-c025-4c1e-b00a-fa59f355cdf9

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
KPI Stimulator, Electrical, Non-Implantable, For Incontinence

GMDN Terms

Code Name
58762 Deep-tissue electromagnetic stimulation system, professional

Identifiers

Type ID
Primary B108899AP2M3MUS00