FDA.reportPublic FDA data

Hensler Bone Press

Primary DI
00853755004003
Brand
Hensler Bone Press
Company
Hensler Surgical
Model
HBP
Catalog number
HBP-001
Device 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.
Published
2019-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYZTrap, Sterile Specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYZTrap, Sterile SpecimenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853755004003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853755004003008537550040038537550040030853755004003

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9103997380julia@henslersurgical.com

Regulatory Flags#

DUNS number
023924230
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853755004232Hensler Surgical Disposable Non-Stick BipolarHSP-0042025-04-03
00853755004249Hensler Surgical Disposable Non-Stick BipolarHSP-0052025-04-03
00853755004256Hensler Surgical Disposable Non-Stick BipolarHSP-0062025-04-03
00853755004263Hensler Surgical Disposable Non-Stick BipolarHSP-0072025-04-03
00853755004270Hensler Surgical Disposable Non-Stick BipolarHSP-0082025-04-03
00853755004287Hensler Surgical Disposable Non-Stick BipolarHSP-0092025-04-03
00853755004294Hensler Surgical Disposable Non-Stick BipolarHSP-0102025-04-03
00853755004300Hensler Surgical Disposable Non-Stick BipolarHSP-0112025-04-03
00853755004317Hensler Surgical Disposable Non-Stick BipolarHSP-0122025-04-03
00853755004324Hensler Surgical Disposable Non-Stick BipolarHSP-0132025-04-03
00853755004331Hensler Surgical Disposable Non-Stick BipolarHSP-0142025-04-03
00853755004348Hensler Surgical Disposable Non-Stick BipolarHSP-0152025-04-03
00853755004355Hensler Surgical Disposable Non-Stick BipolarHSP-0162025-04-03
00853755004379Hensler Surgical Irrigating Non-stick bipolarHSP-IR8152025-04-03
00853755004386Hensler Surgical Irrigating Non-stick bipolarHSP-IR9152025-04-03
00853755004393Hensler Surgical Disposable Non-Stick BipolarHSP-0192025-04-03
00853755004409Hensler Surgical Disposable Non-Stick BipolarHSP-0202025-04-03
00853755004225Hensler Surgical Disposable Non-Stick BipolarHSP-0032025-04-03
10853755004239Hensler Surgical Disposable Non-Stick BipolarHSP-0042025-04-03
10853755004246Hensler Surgical Disposable Non-Stick BipolarHSP-0052025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057578286Polyp TrapsJiangsu Vedkang Medical Science and Technology Co.,Ltd.BYZ2026-05-22
00861092002613CeaLogic Specimen Collection KitRECIBIO, INC.BYZ2026-03-01
04260647240382OsteoPointMorpheus AGBYZ2024-11-26
06975238202561CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2024-07-12
10192253024449ArgyleCardinal Health 200, LLCBYZ2024-02-14
50192253024447ArgyleCardinal Health 200, LLCBYZ2024-02-14
00852360007027Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
10852360007024Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
00852360007003Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM991Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
00860006413903Bone dust trapRIM Medical Technologies IncorporatedBYZ2022-07-10
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28
04260647240122Rebellion Tissue TrapMorpheus AGBYZ2022-06-27
10885632120343MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
50885632120341MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
10885632120336MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
50885632120334MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
00840117310377Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile Dynarex CorporationBYZ2021-04-22
00840117310384Mucus Specimen TrapDYNAREX CORPORATIONBYZ2021-04-22
10080196818624MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196999231MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196818625MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196999232MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196997411MEDLINEMEDLINE INDUSTRIES, INC.BYZ2020-10-28