Adept Medical ArmSure AM0640

GUDID 09421905187374

• ArmSure: To support the patient’s arm. • Arm Strap: To immobilise the patient’s arm, protecting the sterile field. • X-Ray Shield: To provide scatter radiation protection for clinician.

ADEPT MEDICAL LIMITED

Radiological arm/leg positioner

• Primary Device ID: 09421905187374
• NIH Device Record Key: 9af32136-89ce-4fb3-94d1-4c9e2154819e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adept Medical ArmSure
• Version Model Number: AM0640
• Catalog Number: AM0640
• Company DUNS: 592534619
• Company Name: ADEPT MEDICAL LIMITED
• Device Count: 1
• 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: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421905187374 [Primary]

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

[09421905187374]

Liquid Chemical

[09421905187374]

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[09421905187374]

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[09421905187374]

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[09421905187374]

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[09421905187374]

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[09421905187374]

Liquid Chemical

[09421905187374]

Liquid Chemical

[09421905187374]

Liquid Chemical

[09421905187374]

Liquid Chemical

[09421905187374]

Liquid Chemical

[09421905187374]

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[09421905187374]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

Devices Manufactured by ADEPT MEDICAL LIMITED

• 09421905187725 - Adept Medical Overhead Arm Support MR Safe: 2024-08-20 To Support the patient's arms overhead with controller shoulder flexion for imaging. Intended for bores 70cm and upwards
• 09421905187732 - Adept Medical Head Immobiliser: 2024-08-20 Head Immobiliser
• 09421901970475 - Cerumen Hook: 2024-05-01
• 09421901970802 - Jobson Horne Probe - Oval: 2024-05-01
• 09421901970819 - Jobson Horne Probe - Oval, Sterile: 2024-05-01
• 09421901970895 - Rosen Inserter: 2024-05-01
• 09421901970970 - Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Ultra Fine, Non-Sterile: 2024-05-01
• 09421902825026 - Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Non-Sterile: 2024-05-01