FDA.reportPublic FDA data

OmniBone Power Driver

Primary DI
00810563023046
Brand
OmniBone Power Driver
Company
Varian Medical Systems, Inc.
Model
SP-002-1F
Published
2025-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
KNWInstrument, biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230015000OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power DriverLaurane Medical Sas2023-06-16KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810563023046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810563023046008105630230468105630230460810563023046

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, electric, reusableAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118097024
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileGM11003800GM110038002016-09-23
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleGM11003270GM110032702021-02-02
00816389022188Flexible probe, 2.8 mm diameter x 320 mmGM11002280GM110022802016-09-22
00816389022195Mould probe, ø 1.8 diameter x 320 mm, with mandrinGM11002290GM110022902016-09-19
00816389022478Mandrin for 320mm lengthGM11003100GM110031002016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22
00816389022935Catheter flap 200 mm x 290 mm x 10 mm, 40 channelsGM11003910GM110039102016-09-23
00816389024243Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needlesGM11007560GM110075602016-09-22
00816389024250Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needlesGM11007570GM110075702016-09-18
00816389024267Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needlesGM11007580GM110075802016-09-19
00816389025615Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrinGM11010750GM110107502016-09-22
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15