FDA UDI
In Commercial Distribution
🇺🇸 United States
Sparkle Air Water Syringe Tips
DI: 10732224001699
·
Model: BCSAWSCL
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- Sparkle Air Water Syringe Tips
- Primary DI
- 10732224001699
- Version / Model
- BCSAWSCL
- Catalog Number
- BCSAWSCL
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2023-07-17
- Public Version
- 1
- Public Version Date
- 2023-07-25
- Public Version Status
- New
- Public Device Record Key
- 762fe6d0-61a7-4863-9182-67aba0048885
Device Description
Clear
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
- Yes
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECB | UNIT, SYRINGE, AIR AND/OR WATER | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65430 | Dental delivery system irrigation handpiece tip | A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30732224001693 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 10732224001699 | GS1 | ||||
| Unit of Use | 00732224001692 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0167
- [email protected]