FDA UDI
In Commercial Distribution
🇺🇸 United States
Accuject Dental Needles 25G Short
DI: 00020221900507
·
Model: 90050
·
Exel International
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Accuject Dental Needles 25G Short
- Primary DI
- 00020221900507
- Version / Model
- 90050
- Catalog Number
- 900505
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-27
- Public Version
- 4
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 096102e8-93e3-4a66-aa0d-7e26ba2b1002
Device Description
900505 ; ACCUJECT DENTAL NDL. 25GX21MM SHORT, 100/BX, 1000/CS, 6CS/CRTN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10020221900504 | GS1 | Inner Box | 100 | In Commercial Distribution | |
| Primary | 00020221900507 | GS1 | ||||
| Package | 20020221900501 | GS1 | Outer Box | 1000 | In Commercial Distribution | |
| Package | 30020221900508 | GS1 | Shipping Carton | 6000 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861150 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge | |
| Length | 21 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius