SCOTT'S SELECT HEDSTROM FILES 6/pk 21mm # 25
- Primary DI
- D77811241250
- Brand
- SCOTT'S SELECT HEDSTROM FILES 6/pk 21mm # 25
- Company
- SCOTT'S DENTAL SUPPLY L.L.C.
- Model
- 112-4125
- Catalog number
- 112-4125
- Device description
- ENDODONTIC H-FILES (6/pack) Length: 21mm, Size: 25, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23540/s/hedstrom-files-21mm-scott-s-select/
- Published
- 2021-02-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|
| D77811241251 | Primary | HIBCC | 0 | |
| D77811241250 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Rotary/reciprocating endodontic file/rasp, single-use | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 137217043
- Device count
- 6
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
- true
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