Henry Schein
- Primary DI
- 10304040081522
- Brand
- Henry Schein
- Company
- HENRY SCHEIN, INC.
- Model
- 5701052
- Catalog number
- 5701052
- Device description
- Channels PT HT Sample pack
- Published
- 2019-11-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
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 |
|---|---|---|---|---|
| 10304040081522 | Primary | GS1 | 0 | |
| 00304040081525 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10304040081522 | 10304040081522 | ||
| 00304040081525 | 00304040081525 | 304040081525 | 0304040081525 |
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 |
|---|
Regulatory Flags
- DUNS number
- 012430880
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00304040195437 | Henry Schein | 5705824 | 5705824 | 2026-03-17 |
| 00304040195444 | Henry Schein | 5705825 | 5705825 | 2026-03-17 |
| 00304040195420 | Henry Schein | 5705823 | 5705823 | 2026-03-13 |
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| 00304040187524 | Zirlux | 9200052 | 9200052 | 2026-02-04 |
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| 00304040187548 | Zirlux | 9200054 | 9200054 | 2026-02-04 |
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| 00304040187616 | Zirlux | 9200061 | 9200061 | 2026-02-04 |
| 00304040187623 | Zirlux | 9200062 | 9200062 | 2026-02-04 |
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