FlexBoard™ BTM-SX 174630

GUDID 08720168160744

Breast Treatment Module SX for FlexBoard

MACROMEDICS B.V.

Indexed-immobilization patient positioning system

• Primary Device ID: 08720168160744
• NIH Device Record Key: 01c5d1b7-b7e2-4dc0-b47b-09ee96c097ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexBoard™ BTM-SX
• Version Model Number: FB-BTMSX
• Catalog Number: 174630
• 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	08720168160744 [Primary]

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