Avitus Bone Harvester BH-210

GUDID 00857373006036

A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.

AVITUS ORTHOPAEDICS, INC.

Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter
Primary Device ID00857373006036
NIH Device Record Keyac4f5f30-4bdb-426f-8a8c-11ab2a4e03e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvitus Bone Harvester
Version Model NumberBH-210
Catalog NumberBH-210
Company DUNS078269403
Company NameAVITUS ORTHOPAEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857373006036 [Primary]

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-03

On-Brand Devices [Avitus Bone Harvester]

00857373006050A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
00857373006036A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
00857373006029Filter Accessory for REF: BH8 ONLY
00857373006005A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting ti
00857373006074Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone a

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