HELMUT ZEPF
- Primary DI
- EZPF19762000
- Brand
- HELMUT ZEPF
- Company
- Helmut Zepf Medizintechnik GmbH
- Model
- 19.762.00
- Catalog number
- 19.762.00
- Device description
- NEEDLE FOR WATER SYRINGE LUER-LOCK FITTING 19.750.00
- Published
- 2022-11-30
- 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
- false
Product Codes
| Code | Name |
|---|
| ECB | UNIT, SYRINGE, AIR AND/OR WATER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ECB | Unit, Syringe, Air And/Or Water | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EZPF19762000 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental irrigation/aspiration syringe | A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +49742498880 | info@zepf-dental.com |
Regulatory Flags
- DUNS number
- 320001431
- 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
- true
- Sterilization required before use
- true
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