UltraPoint

GUDID 00849593009799

DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE GREEN LEADWIRE 25/Box

AMC

Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use

• Primary Device ID: 00849593009799
• NIH Device Record Key: daf3070e-dfcf-4af5-b8ef-ab3eb6428f51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPoint
• Version Model Number: NM-016395
• Company DUNS: 080242300
• Company Name: AMC
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com
• Phone: 954-345-9800
• Email: info@advantagemed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849593009782 [Unit of Use]
GS1	00849593009799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080914

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

On-Brand Devices [UltraPoint]

• 00849593009737: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL
• 00849593009669: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE OR
• 00849593009812: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 75 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR
• 00849593009799: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR
• 00849593009775: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE GR
• 00849593009751: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL
• 00849593009713: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2 FT. (0.6 M) SINGLE BL
• 00849593009690: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2 FT. (0.6 M) SINGLE OR
• 00849593009652: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE RE