American Medicals
- Primary DI
- B356FF010450
- Brand
- American Medicals
- Company
- American Medicals
- Model
- 1
- Published
- 2022-09-10
- 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
- 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 |
|---|
| B356FF010450 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Ear speculum, reusable | A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Microwave Radiation |
Regulatory Flags
- DUNS number
- 109909627
- Device count
- 1
- DM exempt
- false
- 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
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 06438394002678 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394002685 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394002692 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 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 |
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| 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 |
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| 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 |
| 00810158219106 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219137 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |