BEAR
- Primary DI
- G043802000
- Brand
- BEAR
- Company
- Bear-Ent, LLC
- Model
- 8.02.00
- Catalog number
- 8.02.00
- Device description
- Carpule Syringe with Aspiration, 1.8ml
- Published
- 2022-08-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|
| G043802000 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental anaesthesia syringe, reusable | A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 123551586
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 08800075614421 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-03-05 |
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| 08800075626349 | OSUNG MND | OSUNG MND Co., Ltd. | EJI | 2024-02-23 |
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| 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 |
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| 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 |