FDA UDI
In Commercial Distribution
🇺🇸 United States
Aseptico
DI: 10817417020128
·
Model: AEU-1070SMP-70V
·
ASEPTICO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aseptico
- Primary DI
- 10817417020128
- Version / Model
- AEU-1070SMP-70V
- Company Name
- ASEPTICO, INC.
- Labeler DUNS
- 016853348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-17
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- 69b5b3c9-c7a4-4f79-895e-89af75b27711
- Distribution End Date
- 2033-03-07
Device Description
Dental Implant Motor System
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 |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66227 | Dental surgical power tool motor, electric | A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817417020128 | GS1 |
Customer Contacts
- Phone
- 425-487-3157
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103399 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 28 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity