Identity
- Trade Name
- Berkeley Vacurette FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- VACURETTE STRAIGHT 16 MM (10/PK) FDA UDI
- Model / Reference
- 21561 FDA UDI
- Description
- VACURETTE STRAIGHT 16 MM (10/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925037564 FDA UDI
- 510(k) Number
- K171440 FDA UDI
- FDA Product Code
- HHK FDA UDI
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1175 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical suction system collection container, single-use
Berkeley Vacurette by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical suction system collection container, single-use.
- BEMIS — BEMIS MANUFACTURING CO. · Class II
- Bemis — BEMIS MANUFACTURING CO. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Oxygen Tubing Y-Connector — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- SOMAVAC Waste Collection Unit — SOMAVAC MEDICAL SOLUTIONS, INC. · Class I
- Bemis — BEMIS MANUFACTURING CO. · Class II
- Comfort Chinstrap — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Cleared under the same submission
K171440 also covers:
- BERKELEY — Gyrus Acmi, Inc.
- BERKELEY — Gyrus Acmi, Inc.
- BERKELEY SAFE-TOUCH — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
- Berkeley Vacurette — Gyrus Acmi, Inc.
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI e2d47acf-e64f-472d-bb63-c2caed885e36 34 fields · synced May 30, 2026