FDA UDI
In Commercial Distribution
🇺🇸 United States
ASPIJECT Active Compact
DI: 05713513001185
·
Model: 2041
·
Rønvig Dental Manufacturing A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ASPIJECT Active Compact
- Primary DI
- 05713513001185
- Version / Model
- 2041
- Company Name
- Rønvig Dental Manufacturing A/S
- Labeler DUNS
- 307549241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-27
- Public Version
- 1
- Public Version Date
- 2025-03-07
- Public Version Status
- New
- Public Device Record Key
- 9f17f514-c2b5-4e36-ace9-89ec2f2635f1
Device Description
Aspirating dental injection syringe for 1.8 ml cartridges
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EJI | Syringe, Cartridge | Dental | 872.6770 | 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 | 05713513001185 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.8 | Milliliter |