Darby Dental Supply, LLC
- Primary DI
- 00889813052051
- Brand
- Darby Dental Supply, LLC
- Company
- DARBY DENTAL SUPPLY, LLC
- Model
- 5252471
- Catalog number
- 5252471
- Device description
- NITI FILE MULTI TAPER SX 19MM DARBY
- Published
- 2022-05-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EKS | FILE, PULP CANAL, ENDODONTIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EKS | File, Pulp Canal, Endodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00889813052068 | Primary | GS1 | 0 | |
| 00889813052051 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00889813052068 | 00889813052068 | 889813052068 | 0889813052068 |
| 00889813052051 | 00889813052051 | 889813052051 | 0889813052051 |
GMDN Terms
| Term | Definition |
|---|
| Manual endodontic file/rasp, reusable | A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device. |
Regulatory Flags
- DUNS number
- 825137818
- Device count
- 6
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|
| 00889813067970 | Darby Dental Supply, LLC | 9537746 | | 2026-03-22 |
| 00889813067987 | Darby Dental Supply, LLC | 9537750 | | 2026-03-22 |
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| 10889813067779 | Darby Dental Supply, LLC | 9553143 | | 2025-07-02 |
| 10889813067786 | Darby Dental Supply, LLC | 9553144 | | 2025-07-02 |
| 10889813067793 | Darby Dental Supply, LLC | 9553145 | | 2025-07-02 |
| 10889813067809 | Darby Dental Supply, LLC | 9553146 | | 2025-07-02 |
| 10889813067816 | Darby Dental Supply, LLC | 9553147 | | 2025-07-02 |
| 10889813067823 | Darby Dental Supply, LLC | 9553148 | | 2025-07-02 |
Other Devices Sharing Product Codes
darby.com