OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm

GUDID 10810563022824

VARIAN MEDICAL SYSTEMS, INC.

Bone marrow biopsy needle, single-use
Primary Device ID10810563022824
NIH Device Record Key3caea7df-634c-419d-b207-63861f40b577
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm
Version Model NumberOMM 11/10
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810563022827 [Primary]
GS110810563022824 [Package]
Contains: 00810563022827
Package: [5 Units]
In Commercial Distribution

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 Date2025-09-26
Device Publish Date2025-09-18

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

10810563022725 - OmniBone Bone Biopsy Kit with 11 Gauge 68mm length2025-09-26
10810563022732 - OmniBone Bone Biopsy Kit with 11 Gauge 108mm length2025-09-26
10810563022749 - OmniBone Bone Biopsy Kit with 11 Gauge 158mm length2025-09-26
10810563022824 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm2025-09-26
10810563022824 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm2025-09-26
10810563023036 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm2025-09-26
00810563023046 - OmniBone Power Driver2025-09-26
00810563023053 - OmniBone Charger2025-09-26
00810563023060 - OmniBone Power Driver and Charger2025-09-26

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