Identity
- Trade Name
- Baha FDA UDI
- Generic Name
- Medical device integration rack FDA UDI
- Device Name
- Baha instrument organiser FDA UDI
- Model / Reference
- 92146 FDA UDI
- Description
- Baha instrument organiser FDA UDI
Identifiers
- Catalog Number
- 92146 FDA UDI
- Primary DI / UDI-DI
- 09321502019675 FDA UDI
- 510(k) Number
- K955713 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Medical device integration rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device integration rack
Baha by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device integration rack.
- SpyGlass — Boston Scientific · Class I
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
- JETi™ — Abbott Vascular · Class I
- ENT MR8 — Medtronic Powered Surgical Solutions · Class II
- CENTURION® — Alcon Laboratories, Inc. · Class II
- CONMED — Conmed Corporation · Class I
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
Cleared under the same submission
K955713 also covers:
- Field Bone-Anchored Drill Kit — Cochlear Americas
- Rental Bone-Anchored Drill Kit — Cochlear Americas
- Abutment Cover Black — Cochlear Bone Anchored Solutions AB
- Abutment Cover SilverGray — Cochlear Bone Anchored Solutions AB
- Abutment Inserter — Cochlear Bone Anchored Solutions AB
- Abutment cover blonde — Cochlear Bone Anchored Solutions AB
- Abutment cover brown — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 33e3d57b-f053-47d7-8e72-09a71003c599 36 fields · synced Jun 1, 2026