FDA.reportPublic FDA data

OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm

Primary DI
00810563023039
Brand
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm
Company
Varian Medical Systems, Inc.
Model
OMM 11/15
Published
2025-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

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
10810563023036PackageGS15In Commercial Distribution
00810563023039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081056302303610810563023036
00810563023039008105630230398105630230390810563023039

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Regulatory Flags#

DUNS number
118097024
Device count
1
DM exempt
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
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563022322Temperature Sensor Probe, 18G x 20cmABL-18TP202024-08-09
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRGM11012510GM110125102025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRGM11012750GM110127502025-05-16
00816389029712Retractor, 30 mm, CT/ MRGM11012930GM110129302025-05-16
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesGM11012260GM110122602024-02-19
008105630209538mm CryoprobeDP35-0215-101CRYO-48-F2022-02-18
00810563020984MicroThermX Microwave Ablation System20-17222-001MTX-1802022-02-18
00810563020991MicroThermX Microwave Ablation System20-17222-101MTX180-T22022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0900-101CVA24002022-02-18
008163890289202.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-108CVA2400RA2022-02-18
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceAL09400000AL094000002022-01-09
00856104006000Varian Treatment13.02016-09-16
00856545006027VariSource iX1.2AL19004-0002016-09-16
00856545006034VariSource iX(t)1.2AL19004-0012016-09-16
00816389020986TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD)AL10715008AL107150082016-09-19
00816389021686Intrauterine probe with stopper, angle 30 degrees, length 50 mmGM11000790GM110007902016-09-23
00816389021785Mini-colpostats, pairGM11000900GM110009002016-09-19
00816389022164Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mmGM110022302016-09-22
00816389022386Implant needle, 120 mm, 1.7 mm diameter, curvedGM11002930GM110029302016-09-23

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Primary DI, Brand, Company table
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