Identity
- Trade Name
- Hensler Bone Press FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional accessories are provided with this device outside of what is in the kit. The Hensler Bone Press (HBP) is intended for sterile, single-use with a surgical suction line to collect autologous bone or tissue particles that are utilized in bone fusion. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians. FDA UDI
- Model / Reference
- HBP FDA UDI
- Description
- The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional accessories are provided with this device outside of what is in the kit. The Hensler Bone Press (HBP) is intended for sterile, single-use with a surgical suction line to collect autologous bone or tissue particles that are utilized in bone fusion. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians. FDA UDI
Identifiers
- Catalog Number
- HBP-001 FDA UDI
- Primary DI / UDI-DI
- 00853755004003 FDA UDI
- FDA Product Code
- BYZ FDA UDI
- GMDN Term
- Surgical suction system collection container, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical suction system collection container, single-use
Hensler Bone Press by Hensler Surgical — 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
- Berkeley Vacurette — Gyrus Acmi, Inc. · 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
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
- Hensler Surgical
Sources (1)
- FDA UDI a07b3917-da5a-4bdf-a1e7-1e81e4bdf5d5 36 fields · synced May 30, 2026