FDA UDI
In Commercial Distribution
🇺🇸 United States
CLEARFIL™ DC CORE PLUS Guide tip (L)
DI: EKUR001029KA1
·
Model: #1029-KA
·
KURARAY NORITAKE DENTAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- CLEARFIL™ DC CORE PLUS Guide tip (L)
- Primary DI
- EKUR001029KA1
- Version / Model
- #1029-KA
- Company Name
- KURARAY NORITAKE DENTAL INC.
- Labeler DUNS
- 697119498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-02-17
- Public Version
- 5
- Public Version Date
- 2025-08-27
- Public Version Status
- Update
- Public Device Record Key
- 515995db-e49b-44f5-9edb-f3cd148df66a
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
- Yes
- 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 |
|---|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58399 | Dental material mixing nozzle | A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKUR001029KA1 | HIBCC | ||||
| Unit of Use | EKUR001029KA0 | HIBCC |