FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexible Steel Irrigation Needles .03mm 30 ga
DI: 07540172014564
·
Model: 386493
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flexible Steel Irrigation Needles .03mm 30 ga
- Primary DI
- 07540172014564
- Version / Model
- 386493
- Catalog Number
- 386493
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-17
- Public Version
- 1
- Public Version Date
- 2020-03-25
- Public Version Status
- New
- Public Device Record Key
- e028ca4c-62ea-4b6a-96d1-1ab306c4f486
Device Description
Endodontic irrigation needle
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DZM | NEEDLE, DENTAL | Dental | 872.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45501 | Root canal irrigation handpiece | A hand-operated, air-powered, dental instrument used for the irrigation of prepared root canals to provide thorough debridement of the canal space. It is connected to an air supply via a pressure hose to activate its internal pump mechanism which injects a root canal cleanser via a thin disposable needle into the canal space. This device replaces time consuming manual syringe irrigation and is used for the elimination of pulpal tissue, necrotic materials, and bacteria from the instrumented root canal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540172014564 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 40 x 30ga Needle | ||
| Needle Gauge | 30 | Gauge |