Astek
- Primary DI
- 10840326421908
- Brand
- Astek
- Company
- Young Innovations, Inc.
- Model
- 23013ASTEK3KIT
- Catalog number
- 23013ASTEK3KIT
- Device description
- inSafe Syringe, 2.2ml, Harpoon Asp., Thumb Ring 3 Kit
- Published
- 2023-12-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EJI | Syringe, cartridge |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJI | Syringe, Cartridge | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10840326421908 | Package | GS1 | 1 | In Commercial Distribution |
| 20840326421905 | Package | GS1 | 1 | In Commercial Distribution |
| 00840326421901 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10840326421908 | 10840326421908 | | |
| 20840326421905 | 20840326421905 | | |
| 00840326421901 | 00840326421901 | 840326421901 | 0840326421901 |
GMDN Terms
| Term | Definition |
|---|
| Dental anaesthesia injection kit | A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device. |
Regulatory Flags
- DUNS number
- 004193103
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00840326422663 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 00840326423684 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 00840326423721 | Astek | Young Innovations, Inc. | EJI | 2025-05-27 |
| 05713513001185 | ASPIJECT Active Compact | Rønvig Dental Manufacturing A/S | EJI | 2025-02-27 |
| 05060212057518 | Dental Syringe 85mm, for 2.2ml vial | DTR MEDICAL LIMITED | EJI | 2024-10-11 |
| 05060212057525 | Dental Syringe Long 115mm, for 2.2ml vial | DTR MEDICAL LIMITED | EJI | 2024-10-11 |
| 00813677022882 | PDT, Inc. | PDT, INC. | EJI | 2024-07-01 |
| 00813677022905 | PDT, Inc. | PDT, INC. | EJI | 2024-07-01 |
| 00813677022899 | PDT, Inc. | PDT, INC. | EJI | 2024-06-27 |
| 08800075607799 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614391 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614407 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075614421 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075624994 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
| 08800075607812 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800075626332 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800075626349 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800075626356 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
| 08800053042093 | DENOPS | DENTIS CO. ,LTD | EJI | 2024-01-23 |
| 00840326421741 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 00840326421758 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421769 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421779 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421786 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421790 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421809 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421813 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 20840326421820 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421830 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |
| 10840326421847 | Astek | Young Innovations, Inc. | EJI | 2023-12-01 |