FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTSPLY Tulsa Dental Specialties
DI: 10817417020081
·
Model: AE-250-30-T
·
ASEPTICO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTSPLY Tulsa Dental Specialties
- Primary DI
- 10817417020081
- Version / Model
- AE-250-30-T
- Catalog Number
- AE-250-30-T
- Company Name
- ASEPTICO, INC.
- Labeler DUNS
- 016853348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-15
- Public Version
- 4
- Public Version Date
- 2019-10-16
- Public Version Status
- Update
- Public Device Record Key
- bdc83551-89c0-409e-8d65-a05110146de2
- Distribution End Date
- 2033-06-15
Device Description
HANDPIECE, DIRECT DRIVE, AC-POWERED (MICROMOTOR) Accessory to AEU-27T.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
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 |
|---|---|---|---|---|
| 38347 | Dental power tool system handpiece, line-powered | A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817417020081 | GS1 |
Customer Contacts
- Phone
- 425 487 3157
- [email protected]
- Phone
- 425 487 3157
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Pound |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 69.7 – 101.33 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69.7 – 101.33 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 28 Degrees Celsius