FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Astek
DI: 00843471150870
·
Model: 116201ASTEK
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Astek
- Primary DI
- 00843471150870
- Version / Model
- 116201ASTEK
- Catalog Number
- 116201ASTEK
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 2
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- db15aba7-5455-4d53-ac89-72118af5b43f
- Distribution End Date
- 2023-05-08
Device Description
Belmont BE107 Converter Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| ECB | UNIT, SYRINGE, AIR AND/OR WATER | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45131 | Dental delivery system irrigation handpiece | A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843471150877 | GS1 | Package | 1 | Not in Commercial Distribution | 2023-05-08 |
| Primary | 00843471150870 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]