Wavelength

GUDID 00628108100059

Wavelength TMS Gel 8.45oz

National Therapy Products Inc

Coupling gel, non-sterile Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 00628108100059
• NIH Device Record Key: 4ee684b2-2c95-4a72-9bf6-72633b55db47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wavelength
• Version Model Number: NTPE201X
• Company DUNS: 200149883
• Company Name: National Therapy Products Inc
• Device Count: 1
• 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: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628108100059 [Primary]
GS1	10628108100056 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	20628108100053 [Package]; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012522

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic
• MUI: Media, Coupling, Ultrasound

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: 2019-06-05
• Device Publish Date: 2016-11-16

On-Brand Devices [Wavelength]

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• 00628108100226: Wavelength MP Multi Purpose Ultrasound Gel 100mL
• 00628108100202: Wavelength Multi-Purpose Ultrasound Gel w/ Twist Cap 250 mL
• 00628108100196: Wavelength Ultrasound Gel Clear 250mL
• 00628108100189: Wavelength Multi-Purpose Ultrasound Gel Blue 20L
• 00628108100172: Wavelength CL Multi Purpose Ultrasound Gel 100mL
• 00628108100165: Wavelength Ultrasound Lotion 3.78L
• 00628108100158: Wavelength LV Ultrasound Gel 4L
• 00628108100141: Wavelength MP Multi Purpose Ultrasound Gel 1L
• 00628108100134: Wavelength MP Multi Purpose Ultrasound Gel 16.9oz
• 00628108100127: Wavelength Ultrasound Lotion 5L
• 00628108100110: Wavelength TMS Gel 5L
• 00628108100103: Wavelength MP Multi Purpose Ultrasound Gel 5L
• 00628108100097: Wavelength HV Transmission Gel 5L
• 00628108100080: Wavelength LV Ultrasound Gel 5L
• 00628108100073: Wavelength CL Multi Purpose Ultrasound Gel 5L
• 00628108100066: Wavelength Ultrasound Lotion 8.45oz
• 00628108100059: Wavelength TMS Gel 8.45oz
• 00628108100042: Wavelength MP Multi Purpose Ultrasound Gel 8.45oz
• 00628108100035: Wavelength HV Gel 8.45oz
• 00628108100028: Wavelength LV Ultrasound Gel 8.45oz
• 00628108100011: Wavelength Multi Purpose Ultrasound Gel 8.45oz
• 10628108100346: Wavelength HV Gel High Viscosity w/ twist cap 250 mL
• 10628108100339: Wavelength HV Gel High Viscosity (bottle) 1L
• 10628108100322: Wavelength HV Clear Gel High Viscosity 200 mL
• 10628108100315: Wavelength HV Clear Gel High Viscosity (tube) 100 mL
• 10628108100308: Wavelength Ultrasound Lotion 1 USG
• 10628108100285: Wavelength Multi-Purpose Clear Ultrasound Gel 16.9 oz (500 mL)
• 00628108100271: Wavelength Ultrasound Gel Clear 25g
• 10628108100261: Wavelength LV Ultrasound Gel Low Viscosity 100mL
• 10628108100254: Wavelength MP Multi Purpose Ultrasound Gel 8.45 oz
• 00628108100400: Wavelength CL Ultrasound Gel Medium Viscosity 480mL
• 00628108100394: Wavelength MP Ultrasound Gel Medium Viscosity 480mL