Wedge 7 CF ExaFix™ 110540

GUDID 08719425700939

Carbon fiber wedge, fit for ExaFix, 7 degrees (for hyper extension)

MACROMEDICS B.V.

Indexed-immobilization patient positioning system

• Primary Device ID: 08719425700939
• NIH Device Record Key: 4513fb4c-b2bb-4482-b1c6-b4f2c13e34e5
• Commercial Distribution Discontinuation: 2022-06-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Wedge 7 CF ExaFix™
• Version Model Number: CFW7
• Catalog Number: 110540
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719425700939 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-21
• Device Publish Date: 2016-12-31

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