FDA UDI
In Commercial Distribution
🇺🇸 United States
Brasseler USA
DI: 00887919853848
·
Model: 5027135RF
·
Peter Brasseler Holdings, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Brasseler USA
- Primary DI
- 00887919853848
- Version / Model
- 5027135RF
- Company Name
- Peter Brasseler Holdings, LLC
- Labeler DUNS
- 082080136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-19
- Public Version
- 1
- Public Version Date
- 2023-01-27
- Public Version Status
- New
- Public Device Record Key
- cf706142-cf1e-414c-9378-a061889145b8
Device Description
ENDOSYNC PLUS
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKX | Handpiece, direct drive, ac-powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45420 | Dental laboratory power tool system | An assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an enclosed and flexible spinning cable (e.g., a Bowden cable), and a variety of dental power tool attachments to hold the active instruments (e.g., drills, burs, grind wheels). The spinning cable provides power to the handpiece from the electric motor which is placed distant from the site of operation, providing additional protection from exposure to electrical current. The system is typically combined with various speed controllers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887919853848 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112665 | 000 |