FDA UDI
In Commercial Distribution
🇺🇸 United States
BTC - Medical Equipment
DI: 08050038700016
·
Model: EDGE P
·
BTC SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- BTC - Medical Equipment
- Primary DI
- 08050038700016
- Version / Model
- EDGE P
- Catalog Number
- 9110501
- Company Name
- BTC SRL
- Labeler DUNS
- 387634079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 2
- Public Version Date
- 2022-03-21
- Public Version Status
- Update
- Public Device Record Key
- 03780144-fd25-4856-a692-936e931d1d05
Device Description
EDGE P is the ultimate concept developed by BTC specifically designed for Podiatry and Pedicure. EDGE P is an innovative Examination/Procedure Chair with a modern design whose key words are: Solidity and Technical Innovation.
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
- Yes
- 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 |
|---|---|---|---|---|
| GBB | Chair, Surgical, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47150 | Podiatric chair, electric | A mains electricity (AC-powered) device designed to support a patient in a seated position and to facilitate foot examination, treatment, and/or minor surgery procedures. It is typically adjustable in height and includes armrests and a reclining back that may be tilted from a vertical to a horizontal position. It usually includes individual leg sections and footrests with lifting and rotating capabilities; some types can be programmed to several standard positions. Devices intended for foot examination and/or treatment may be attached as components of the chair (and may be operated using the chair controls), or stand separately as self-supported or wall-mounted units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08050038700016 | GS1 |
Customer Contacts
- Phone
- +390542643664
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius