mytaMed
- Primary DI
- B351608310
- Brand
- mytaMed
- Company
- Mytamed, Inc.
- Model
- 6.08.31
- Catalog number
- 6.08.31
- Device description
- Farrior Ear Specula, Oval-Oblique, #1
- Published
- 2018-02-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| ERA | Otoscope |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B351608310 | 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 |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 015903922
- 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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| B351B620120 | BEAR | 6.20.12 | 6.20.12 | 2020-05-28 |
| B351B620130 | BEAR | 6.20.13 | 6.20.13 | 2020-05-28 |
| B351B620140 | BEAR | 6.20.14 | 6.20.14 | 2020-05-28 |
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| B351B706290 | BEAR | 7.06.29 | 7.06.29 | 2020-05-12 |
| B351B706300 | BEAR | 7.06.30 | 7.06.30 | 2020-05-12 |
| B351B706310 | BEAR | 7.06.31 | 7.06.31 | 2020-05-12 |
| B351B706320 | BEAR | 7.06.32 | 7.06.32 | 2020-05-12 |
| B351B706340 | BEAR | 7.06.34 | 7.06.34 | 2020-05-12 |
| B351B707260 | BEAR | 7.07.26 | 7.07.26 | 2020-05-12 |
| B351B810100 | BEAR | 8.10.10 | 8.10.10 | 2020-05-19 |
| B351B707270 | BEAR | 7.07.27 | 7.07.27 | 2020-05-12 |
| B351B707290 | BEAR | 7.07.29 | 7.07.29 | 2020-05-12 |
| B351B707300 | BEAR | 7.07.30 | 7.07.30 | 2020-05-12 |
| B351B810050 | BEAR | 8.10.05 | 8.10.05 | 2020-05-19 |
| B351B810060 | BEAR | 8.10.06 | 8.10.06 | 2020-05-19 |
| B351B810070 | BEAR | 8.10.07 | 8.10.07 | 2020-05-19 |
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