FDA UDI
In Commercial Distribution
🇺🇸 United States
Baha
DI: 09321502016292
·
Model: 90784
·
Cochlear Bone Anchored Solutions AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Baha
- Primary DI
- 09321502016292
- Version / Model
- 90784
- Catalog Number
- 90784
- Company Name
- Cochlear Bone Anchored Solutions AB
- Labeler DUNS
- 559784736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-03
- Public Version
- 4
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- 634de104-c4dd-4516-bb48-e2c12b6a0cf5
Device Description
Case anthracite with insert Divino
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXB | Hearing aid, bone conduction | Ear, Nose, Throat | 874.3302 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66209 | Valve-non-specific transcatheter heart valve bioprosthesis | An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant heart valve or a previously-implanted heart valve prosthesis, via percutaneous transcatheter access, and that is not dedicated to replacement of any one of the four heart valves (valve-non-specific). It is comprised of the processed xenograft attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices used to facilitate implantation (e.g., catheter) at the chosen valve location are typically included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502016292 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042017 | 000 |