EPAD 100085

GUDID 00851641007008

Full EPAD System

SAFEOP SURGICAL, INC.

Evoked-potential graphic recording system

• Primary Device ID: 00851641007008
• NIH Device Record Key: 48938c9d-f3ee-4637-98c2-99076ffb6e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPAD
• Version Model Number: EPAD
• Catalog Number: 100085
• Company DUNS: 078641162
• Company Name: SAFEOP SURGICAL, INC.
• 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: 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

Customer Support Contacts

• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com
• Phone: 4107739601
• Email: info@safeopsurgical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851641007008 [Primary]

FDA Product Code

• IKN: Electromyograph, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-14

On-Brand Devices [EPAD]

• 00851641007237: EPAD NMJ Electrodes Pouch Kit
• 00851641007251: EPAD Peripheral Electrode Pouch Kit
• 00851641007213: EPAD Cervical Electrodes Pouch Kit
• 00851641007176: EPAD Acquisition white right NMJ with ground cable
• 00851641007169: EPAD Acquisition red left short no erbs cable
• 00851641007152: EPAD Acquisition white right short no erbs cable
• 00851641007145: EPAD Stim blue left short cable
• 00851641007138: EPAD Stim yellow right short cable
• 00851641007121: EPAD Acquisition red left short cable
• 00851641007114: EPAD Acquisition white right short cable
• 00851641007107: EPAD Stim blue left long cable
• 00851641007091: EPAD Stim yellow right long cable
• 00851641007084: Acquisition red left long cable
• 00851641007077: EPAD Acquisition white right long cable
• 00851641007060: EPAD USB OTG Cable
• 00851641007053: EPAD USB-A to MICRO USB-A Cable
• 00851641007046: EPAD wireless charger for EPAD Tablet 100086
• 00851641007039: EPAD Tablet Staged
• 00851641007022: EPAD POWER SUPPLY
• 00851641007015: EPAD Control Box /Head Box
• 00851641007008: Full EPAD System