OmniBoard™ 3.0 base,RE 174210

GUDID 08720168162304

OmniBoard 3.0 RealEase

MACROMEDICS B.V.

Indexed-immobilization patient positioning system

• Primary Device ID: 08720168162304
• NIH Device Record Key: 835896d6-a98d-4f80-ad6e-5629a197e982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniBoard™ 3.0 base,RE
• Version Model Number: UATB-BPR3.0
• Catalog Number: 174210
• Company DUNS: 489730120
• Company Name: MACROMEDICS B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720168162304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142420

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2023-05-01
• Device Publish Date: 2023-04-21

Devices Manufactured by MACROMEDICS B.V.

• 08719425702193 - T-Grip for EagleBoard™ MR: 2023-05-01 T-Grip for EagleBoard, MR safe
• 08719425702209 - U-Grip for EagleBoard™ MR: 2023-05-01 U-Grip for EagleBoard, MR safe
• 08719425702254 - Profiles BreastBoardSX™ set/2: 2023-05-01 Carbon fiber profile breast mask for BreastBoard SX or OmniBoard Breast Treatment Module, set of 2
• 08719425702339 - Shoulder retr. for LEPS™,set/2: 2023-05-01 Shoulder retractor for use with LEPS, set of 2
• 08719425702759 - HighBridgeSupport RE: 2023-05-01 High Bridge Support (RealEase) for lowerarms, carbon fiber
• 08719425703978 - MaxSupport™ Extender: 2023-05-01 MaxSupport Extender
• 08719425704005 - Upper AS TS/MBLX, set/2: 2023-05-01 Upper adjustable arm supports with high armcup, set of 2
• 08719425704029 - Cranial AS for BBLX/TS, set/2: 2023-05-01 Cranial adjustable arm supports with high armcup, set of 2