ZARC
- Primary DI
- 06975718052198
- Brand
- ZARC
- Company
- Shenzhen Denco Medical Co., Ltd
- Model
- BlueShaper PRO sterile files 25mm Z7 (6 units)
- Published
- 2025-07-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- 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 |
|---|
| 06975718052198 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 06975718052198 | 06975718052198 | 6975718052198 |
GMDN Terms
| Term | Definition |
|---|
| Manual endodontic file/rasp, single-use | 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 single-use device. |
Regulatory Flags
- DUNS number
- 543035008
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 06942512502266 | AVALON BIOMED | Z-Micro Opener 10.04 (3 units) | ZMO1 | 2025-11-25 |
| 06942512509166 | AVALON BIOMED | Z-Micro Shaper 20 .02 (3 units) | ZMS1 | 2025-11-25 |
| 06942512509173 | AVALON BIOMED | Z-Micro Shaper 25 .02 (3 units) | ZMS2 | 2025-11-25 |
| 06942512509180 | AVALON BIOMED | Z-Micro Shaper 30 .02 (3 units) | ZMS3 | 2025-11-25 |
| 06942512509197 | AVALON BIOMED | Z-Micro Shaper ASSORTED (3 units) | ZMSA | 2025-11-25 |
| 06942512509203 | AVALON BIOMED | Z-Micro Opener 15.04 (3 units) | ZMO2 | 2025-11-25 |
| 06942512509210 | AVALON BIOMED | Z-Micro Opener 20.04 (3 units) | ZMO3 | 2025-11-25 |
| 06942512509227 | AVALON BIOMED | Z-Micro Opener ASSORTED (3 units) | ZMOA | 2025-11-25 |
| 06942512500637 | AVALON BIOMED | BlueShaper sterile files 19mm ZX (6 units) | | 2025-07-21 |
| 06942512500644 | AVALON BIOMED | BlueShaper sterile files 21mm Z2 (6 units) | | 2025-07-21 |
| 06942512500651 | AVALON BIOMED | BlueShaper sterile files 21mm Z5 (6 units) | | 2025-07-21 |
| 06942512500668 | AVALON BIOMED | BlueShaper sterile files 21mm Z6 (6 units) | | 2025-07-21 |
| 06942512500675 | AVALON BIOMED | BlueShaper sterile files 21mm Z7 (6 units) | | 2025-07-21 |
| 06942512500682 | AVALON BIOMED | BlueShaper sterile files 21mm Z1-Z4 (4 units) | | 2025-07-21 |
| 06942512500699 | AVALON BIOMED | BlueShaper sterile files 25mm Z7 (6 units) | | 2025-07-21 |
| 06942512500705 | AVALON BIOMED | BlueShaper sterile files 25mm Z1-Z4 (4 units) | | 2025-07-21 |
| 06942512500712 | AVALON BIOMED | BlueShaper sterile files 31mm ZX-Z5 (6 units) | | 2025-07-21 |
| 06942512500729 | AVALON BIOMED | BlueShaper sterile files 31mm Z1 (6 units) | | 2025-07-21 |
| 06942512500736 | AVALON BIOMED | BlueShaper sterile files 31mm Z2 (6 units) | | 2025-07-21 |
| 06942512500743 | AVALON BIOMED | BlueShaper sterile files 31mm Z5 (6 units) | | 2025-07-21 |
Other Devices Sharing Product Codes