OEC 00195278096944

GUDID 00195278096944

MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC 3D

OEC MEDICAL SYSTEMS, INC.

Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00195278096944
• NIH Device Record Key: 65c45b5b-1020-40cb-941c-7b2b2e33dcdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEC
• Version Model Number: 3D
• Catalog Number: 00195278096944
• Company DUNS: 085305274
• Company Name: OEC MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx
• Phone: +1(801)328-9300
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278096944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203346

FDA Product Code

• OWB: Interventional fluoroscopic x-ray system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-23
• Device Publish Date: 2021-04-15

On-Brand Devices [OEC]

• 00840682121729: ELITE
• 00840682114349: 9800 PLUS
• 00840682114301: 9900 ELITE
• 00195278096944: MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC 3D