EKCOMED EKM-CFMA100

GUDID 00850000965119

Universal Head Positioner

EKCOMED, LLC

Limb/torso/head restraint, single-use

• Primary Device ID: 00850000965119
• NIH Device Record Key: 462153af-b402-4cbf-b692-74b73a7823b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKCOMED
• Version Model Number: EKM-CFMA100
• Catalog Number: EKM-CFMA100
• Company DUNS: 178249053
• Company Name: EKCOMED, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com
• Phone: 800-517-1833
• Email: info@ekcomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000965119 [Primary]
GS1	10850000965116 [Unit of Use]

FDA Product Code

• CCX: Support, Patient Position

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: 2022-11-04
• Device Publish Date: 2022-10-27

On-Brand Devices [EKCOMED]

• 00850000965133: Perineal Post Roll
• 00850000965126: SAN Shoulder Suspension Kit
• 00850000965119: Universal Head Positioner
• 00850000965102: Ankle Distraction Kit
• 00850000965096: V-Critter Face Mask
• 00850000965089: Shoulder Suspension sleeve V Kit
• 00850000965072: McPull Shoulder Kit
• 00850000965065: DKP Knee Kit
• 00850000965058: TBC Shoulder Kit
• 00850000965041: Shoulder Suspension Sleeve Kit
• 00850000965034: Critter Stabilization Device
• 00850000965027: Critter Face Mask
• 00850000965010: SUREtriever Suture Retriever
• 00850000965003: Shoulder Suspension Kit