OmniBone Charger

GUDID 00810563023053

Varian Medical Systems, Inc.

Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Primary Device ID00810563023053
NIH Device Record Key46f3b0a5-03c8-4ae3-9208-6b4062dd4c08
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniBone Charger
Version Model NumberSP-002-8F
Company DUNS118097024
Company NameVarian Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810563023053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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
10810563023036 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm2025-09-26
00810563023046 - OmniBone Power Driver2025-09-26
00810563023053 - OmniBone Charger2025-09-26
00810563023053 - OmniBone Charger2025-09-26
00810563023060 - OmniBone Power Driver and Charger2025-09-26

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