HU-FRIEDY
- Primary DI
- 10889950083014
- Brand
- HU-FRIEDY
- Company
- HU-FRIEDY MFG. CO., LLC
- Model
- PI5447
- Catalog number
- PI5447
- Device description
- Calcium Hydroxide Place Large, Satin Ste
- Published
- 2020-11-12
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10889950083014 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10889950083014 | 10889950083014 |
GMDN Terms
| Term | Definition |
|---|
| Dental material application tool, single-use | A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 005085972
- 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
- 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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| 06438394020382 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394010956 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 00198506089619 | ELMED INCORPORATED | ELMED INCORPORATED | MDM | 2026-03-17 |
| 00888867519459 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519473 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519503 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519510 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529755 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529793 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529823 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00198506089510 | ELMED INCORPORATED | ELMED INCORPORATED | MDM | 2026-03-13 |
| 00810158219236 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219243 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219250 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219281 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219304 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219311 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219359 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219373 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219007 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219014 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219021 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219038 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219069 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219090 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
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