FDA UDI
In Commercial Distribution
🇺🇸 United States
Health-Tec/DHP Irrigating Needle Tips
DI: D773130100041
·
Model: 130-10004
·
Dental Health Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Health-Tec/DHP Irrigating Needle Tips
- Primary DI
- D773130100041
- Version / Model
- 130-10004
- Catalog Number
- 130-10004
- Company Name
- Dental Health Products Inc
- Labeler DUNS
- 623191194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-19
- Public Version
- 1
- Public Version Date
- 2022-10-27
- Public Version Status
- New
- Public Device Record Key
- 0e694cf3-0c71-4caf-9d2d-bd503e571dc2
Device Description
Health-Tec/DHP Irrigating needle Tips 23ga. Blue 25/bag
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| EIC | Syringe, Periodontic, Endodontic, Irrigating | 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 |
|---|---|---|---|---|---|---|
| Primary | D773130100041 | HIBCC |