Ponto
- Primary DI
- 05712149000562
- Brand
- Ponto
- Company
- Oticon Medical AB
- Model
- M50384
- Catalog number
- M50384
- Device description
- Screwdriver, machine, 35mm
- Published
- 2016-09-16
- 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
- false
Related Records
Contact Domains
oticonmedical.comProduct Codes
| Code | Name |
|---|---|
| MAH | Hearing Aid, Bone Conduction, Implanted |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| MAH | Hearing Aid, Bone Conduction, Implanted | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05712149000562 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05712149000562 | 05712149000562 | 5712149000562 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical screwdriver, reusable | A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| 888-277-8014 | info@oticonmedical.com |
Regulatory Flags
- DUNS number
- 554563994
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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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|---|---|---|---|---|
| 05712149027590 | Genie Medical | 275203 | 275203 | 2024-08-08 |
| 05712149027637 | Genie Medical | 275209 | 275209 | 2024-08-08 |
| 05712149027644 | Genie Medical | 275351 | 275351 | 2024-08-08 |
| 05712149025459 | Sentio | 205338 | 205338 | 2024-07-22 |
| 05712149025466 | Sentio | 205339 | 205339 | 2024-07-22 |
| 05712149025473 | Sentio | 205340 | 205340 | 2024-07-22 |
| 05712149025480 | Sentio | 205341 | 205341 | 2024-07-22 |
| 05712149025497 | Sentio | 205342 | 205342 | 2024-07-22 |
| 05712149025503 | Sentio | 205343 | 205343 | 2024-07-22 |
| 05712149026906 | Sentio | 186323 | 186323 | 2024-07-22 |
| 05712149027408 | Screwdriver HexaDrive | 265497 | 265497 | 2024-06-14 |
| 05712149027255 | Ponto | 256950 | 256950 | 2023-08-21 |
| 05712149027262 | Ponto | 254434 | 254434 | 2023-08-21 |
| 05712149027279 | Ponto | 254436 | 254436 | 2023-08-21 |
| 05712149027453 | Ponto | 267634 | 267634 | 2023-08-21 |
| 05712149027460 | Ponto | 267635 | 267635 | 2023-08-21 |
| 05712149027477 | Ponto | 267636 | 267636 | 2023-08-21 |
| 05712149027484 | Ponto | 267637 | 267637 | 2023-08-21 |
| 05712149027491 | Ponto | 267638 | 267638 | 2023-08-21 |
| 05712149027507 | Ponto | 267639 | 267639 | 2023-08-21 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05712149026494 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026500 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026517 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026524 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026531 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026548 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026555 | Ponto | Oticon Medical AB | MAH | 2022-04-01 |
| 05712149026319 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026432 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026449 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026456 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026463 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026470 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026487 | Ponto | Oticon Medical AB | MAH | 2021-09-01 |
| 05712149026302 | Ponto | Oticon Medical AB | MAH | 2021-03-31 |
| 09321502043847 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2020-01-25 |
| 09321502043854 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2020-01-25 |
| 09321502043892 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-22 |
| 09321502043908 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-22 |
| 09321502043861 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 09321502043878 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 09321502043885 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 09321502043915 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 09321502043922 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 09321502043939 | Baha | Cochlear Bone Anchored Solutions AB | MAH | 2019-05-16 |
| 05712149025091 | Ponto | Oticon Medical AB | MAH | 2018-10-24 |
| 05712149025107 | Ponto | Oticon Medical AB | MAH | 2018-10-24 |
| 05712149000326 | Ponto | Oticon Medical AB | MAH | 2016-09-16 |
| 05712149000586 | Ponto | Oticon Medical AB | MAH | 2016-09-16 |
| 05712149000647 | Ponto | Oticon Medical AB | MAH | 2016-09-16 |