Identity
- Trade Name
- Field Bone-Anchored Drill Kit FDA UDI
- Generic Name
- Bone-conduction hearing implant system implantation tool FDA UDI
- Model / Reference
- 91053R FDA UDI
Identifiers
- Catalog Number
- 91053R FDA UDI
- Primary DI / UDI-DI
- 09321502030434 FDA UDI
- 510(k) Number
- K955713 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Bone-conduction hearing implant system implantation tool 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone-conduction hearing implant system implantation tool
Field Bone-Anchored Drill Kit by Cochlear Americas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-conduction hearing implant system implantation tool.
- Baha — Cochlear Bone Anchored Solutions AB · Class I
- Osscora Foot Control — Cochlear Bone Anchored Solutions AB · Class II
- Rental Bone-Anchored Drill Kit — Cochlear Americas · Class II
Cleared under the same submission
K955713 also covers:
- 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
- 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 |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA UDI 3678bdda-04da-439f-b2d9-591bbfece747 35 fields · synced Jun 8, 2026