Galaxy™
- Primary DI
- 10190707192577
- Brand
- Galaxy™
- Company
- Ortho Organizers, Inc.
- Model
- H118L
- Device description
- GALAXY Debonding Carbides 118L 18 Fluted/High Speed 5/pk
- Published
- 2025-10-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EHM | STRIP, POLISHING AGENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EHM | Strip, Polishing Agent | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00190707192570 | Primary | GS1 | 0 | |
| 10190707192577 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00190707192570 | 00190707192570 | 190707192570 | 0190707192570 |
| 10190707192577 | 10190707192577 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental abrasive strip, single-use | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 062165188
- Device count
- 5
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
| 10190707068148 | VARIABLE FORCE 3™ THERMAL NITANIUM® ARCHWIRE | 104-967 | 2026-01-07 | |
| 10190707086494 | Triumph® | 205-011 | 2026-01-07 | |
| 00190707086503 | Triumph® | 205-206B | 2026-01-07 | |
| 10190707086517 | Triumph® | 205-206T | 2026-01-07 | |
| 10190707086524 | Triumph® | 205-207T | 2026-01-07 | |
| 10190707086531 | Triumph® | 205-207TT | 2026-01-07 | |
| 00190707102975 | Carriere® Motion Pro™ | 425-818C | 2024-01-16 | |
| 00190707103002 | Carriere® Motion Pro™ | 425-820C | 2024-01-16 | |
| 00190707103033 | Carriere® Motion Pro™ | 425-823C | 2024-01-16 | |
| 00190707103064 | Carriere® Motion Pro™ | 425-825C | 2024-01-16 | |
| 00190707103095 | Carriere® Motion Pro™ | 425-827C | 2024-01-16 | |
| 00190707075972 | Maestro® Band Assemblies | 902-351061E | 2020-07-14 | |
| 00190707096755 | Reveal® Aligners | 139-6104 | 2022-01-06 | |
| 00190707096762 | Reveal® Aligners | 139-6105 | 2022-01-06 | |
| 00190707096779 | Reveal® Aligners | 139-6106 | 2022-01-06 | |
| 00190707096786 | Reveal® Aligners | 139-6107 | 2022-01-06 | |
| 00190707096793 | Reveal® Aligners | 139-6109 | 2022-01-06 | |
| 00190707096809 | Reveal® Aligners | 139-6108 | 2022-01-06 | |
| 00190707096816 | Reveal® Aligners | 139-6110 | 2022-01-06 | |
| 00190707096823 | Reveal® Aligners | 139-6111 | 2022-01-06 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07908738730509 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-13 |
| 07908738730516 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-13 |
| 07908738730554 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-13 |
| 07908738730561 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-13 |
| 07908738730578 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-13 |
| 07908738730301 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730318 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730325 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730332 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730356 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730363 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730370 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730387 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730394 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730400 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730417 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730424 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730431 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730448 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730455 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 07908738730462 | DENFINITY | 3R - INDUSTRIA E COMERCIO EIRELI | EHM | 2026-03-10 |
| 10190707192270 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192287 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192294 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192300 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192317 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192324 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192331 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 10190707192348 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |
| 00190707192358 | Galaxy™ | Ortho Organizers, Inc. | EHM | 2025-10-23 |