Avitus Bone Harvester BH-220

GUDID 00857373006074

Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.

AVITUS ORTHOPAEDICS, INC.

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Primary Device ID00857373006074
NIH Device Record Keydc1c13c5-482b-42c8-8918-c1cf2c8a14a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvitus Bone Harvester
Version Model NumberBH-220
Catalog NumberBH-220
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
GS100857373006074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

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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