Ponto
- Primary DI
- 05712149000296
- Brand
- Ponto
- Company
- Oticon Medical AB
- Model
- M50220
- Catalog number
- M50220
- Device description
- Implant, 4 mm
- Published
- 2015-09-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|---|---|---|---|
| 05712149000296 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05712149000296 | 05712149000296 | 5712149000296 |
GMDN Terms
| Term | Definition |
|---|---|
| Craniofacial bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Length | 4 | Millimeter |
| Outer Diameter | 3.75 | Millimeter |
Sterilization Methods
| Method |
|---|
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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 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 |
| 05712149000562 | Ponto | Oticon Medical AB | MAH | 2016-09-16 |
| 05712149000586 | Ponto | Oticon Medical AB | MAH | 2016-09-16 |