FDA UDI
In Commercial Distribution
🇺🇸 United States
EXEL CURVED TIP 10ml SYRINGE
DI: 00020221262674
·
Model: 26267
·
Exel International
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- EXEL CURVED TIP 10ml SYRINGE
- Primary DI
- 00020221262674
- Version / Model
- 26267
- Catalog Number
- 26267
- Company Name
- Exel International
- Labeler DUNS
- 180572216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-15
- Public Version
- 1
- Public Version Date
- 2023-03-23
- Public Version Status
- New
- Public Device Record Key
- 9641a2ba-ecf6-432d-a941-42591eccc829
Device Description
EXEL CURVED TIP 10ml SYRINGE; BULK, NON-STERILE, 50PC/BX, 500PC/CS, 2CS/CRTN
Device Characteristics
- Single Use
- Yes
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35390 | Irrigation syringe | A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10020221262671 | GS1 | Inner box | 50 | In Commercial Distribution | |
| Primary | 00020221262674 | GS1 | ||||
| Package | 20020221262678 | GS1 | Outer box | 10 | In Commercial Distribution | |
| Package | 30020221262675 | GS1 | Shipping carton | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861153 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius