FDA UDI
In Commercial Distribution
🇺🇸 United States
STERLING
DI: 00366975013040
·
Model: 5259-507
·
BENCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STERLING
- Primary DI
- 00366975013040
- Version / Model
- 5259-507
- Company Name
- BENCO DENTAL SUPPLY CO.
- Labeler DUNS
- 015108087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-13
- Public Version
- 3
- Public Version Date
- 2024-02-02
- Public Version Status
- Update
- Public Device Record Key
- 6274ffe9-9101-43f6-affa-be7d2b4d5427
Device Description
STERLING Handpiece 1:5 Increasing Fiber-Optic ERL 95 1:5
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 |
|---|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12352 | Fibreoptic dental light | A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00366975013040 | GS1 |
Customer Contacts
- Phone
- +1 (570) 602-6924
- [email protected]