FDA UDI
In Commercial Distribution
🇺🇸 United States
BTL Cellutone handpiece
DI: B108714GUNALXC1040
·
Model: BTL Cellutone handpiece
·
BTL INDUSTRIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BTL Cellutone handpiece
- Primary DI
- B108714GUNALXC1040
- Version / Model
- BTL Cellutone handpiece
- Company Name
- BTL INDUSTRIES LIMITED
- Labeler DUNS
- 733532951
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8636f03f-af1c-41e1-9c30-986a1e8b770f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34489 | Pneumatic massager | An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B108714GUNALXC1040 | HIBCC |