FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ-Swivel
DI: 00990010306455
·
Model: HP2069
·
Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EZ-Swivel
- Primary DI
- 00990010306455
- Version / Model
- HP2069
- Catalog Number
- EZ-Swivel N E6
- Company Name
- Beyes Dental Canada Inc
- Labeler DUNS
- 244261462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-27
- Public Version
- 1
- Public Version Date
- 2024-01-04
- Public Version Status
- New
- Public Device Record Key
- 4b277a16-e6cf-41a2-97f1-fb5bca9ac415
Device Description
EZ-Swivel N E6, Coupler E6, 6 Holes, Optic
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 45121 | Pneumatic dental handpiece coupler | A short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00990010306455 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101551 | 000 |