FDA UDI
In Commercial Distribution
🇺🇸 United States
HOSE LIGHT MOTOR
DI: J00716012480011
·
Model: 1601248-001
·
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HOSE LIGHT MOTOR
- Primary DI
- J00716012480011
- Version / Model
- 1601248-001
- Company Name
- BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
- Labeler DUNS
- 338234588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-25
- Public Version
- 2
- Public Version Date
- 2026-02-11
- Public Version Status
- Update
- Public Device Record Key
- a5a0f25f-a3fa-41c4-9582-2711285d3477
Device Description
The hoses, also called “tuyaux” (“TY”), are accessories used to connect the micromotor to a dental unit or to a table-top device. For all hoses, the main function is to deliver electrical power, air and water to the micromotor.
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40593 | Pneumatic dental power tool hose | A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed gas from a source to a dental drilling system handpiece to provide power to the turbine. The device is of an adequate length to provide manoeuvrability of the handpiece. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00716012480011 | HIBCC |
Customer Contacts
- Phone
- +1 949-477-6050
- [email protected]