FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Ultra Safety Plus Twist kit 30G Extra Short
DI: 03701398105281
·
Model: 01N4500
·
SEPTODONT SAS SPECIALITES SEPTODONT
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
101
Basic Information
- Brand Name
- Ultra Safety Plus Twist kit 30G Extra Short
- Primary DI
- 03701398105281
- Version / Model
- 01N4500
- Company Name
- SEPTODONT SAS SPECIALITES SEPTODONT
- Labeler DUNS
- 275273795
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 101
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 1
- Public Version Date
- 2022-10-10
- Public Version Status
- New
- Public Device Record Key
- d86f7a74-2bc5-47c9-95c2-ca6ba96807f1
- Distribution End Date
- 2022-09-30
Device Description
100 30G Extra Short (Purple) needles and 1 handle (to be sterilized)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJI | Syringe, Cartridge | Dental | 872.6770 | 2 |
| DZM | Needle, Dental | Dental | 872.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12740 | Dental syringe needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 03701398102709 | GS1 | ||||
| Primary | 03701398105281 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius