Identity
- Trade Name
- Capseus Surgical FDA UDI
- Generic Name
- Bone dust vacuum system FDA UDI
- Device Name
- Bone Dust Collector - 9646 FDA UDI
- Model / Reference
- BDC-15 FDA UDI
- Description
- Bone Dust Collector - 9646 FDA UDI
Identifiers
- Catalog Number
- BDC-15 FDA UDI
- Primary DI / UDI-DI
- 10665973027118 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Bone dust vacuum system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone dust vacuum system
Capseus Surgical by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dukal LLC
Sources (1)
- FDA UDI 8361e694-f717-4ade-bc0c-8adcf62ce837 35 fields · synced May 30, 2026