FDA UDI
In Commercial Distribution
🇺🇸 United States
PLUNGER FOR PAROJECT-HF02500A1
DI: 00303620000031
·
Model: 01N2042
·
SEPTODONT, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PLUNGER FOR PAROJECT-HF02500A1
- Primary DI
- 00303620000031
- Version / Model
- 01N2042
- Company Name
- SEPTODONT, INC
- Labeler DUNS
- 012925513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- f161a04f-e160-45f4-8359-21ee8312146f
Device Description
Spare part for dental cartridge syringe
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EGM | Injector, Jet, Mechanical-Powered | Dental | 872.4475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35969 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00303620000031 | GS1 |
Customer Contacts
- Phone
- (303) 665-7535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904279 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.8 | Milliliter |