Neurotips

GUDID 00384705405033

Sterile single use neuropathy screening pins

OWEN MUMFORD LIMITED

Pressure algometer/aesthesiometer, mechanical Pressure algometer/aesthesiometer, mechanical

• Primary Device ID: 00384705405033
• NIH Device Record Key: 597e5e88-68e7-4fb7-8426-8b3979fba0b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurotips
• Version Model Number: NT 0100
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD LIMITED
• Device Count: 100
• 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: 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: true

Customer Support Contacts

• Phone: 770-977-2226
• Email: info.us@owenmumford.com
• Phone: 770-977-2226
• Email: info.us@owenmumford.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384705405002 [Unit of Use]
GS1	00384705405019 [Primary]
GS1	00384705405026 [Package]; Contains: 00384705405019; Package: Sleeve [5 Units]; In Commercial Distribution
GS1	00384705405033 [Package]; Contains: 00384705405026; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• GXB: Esthesiometer

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: 2019-10-11
• Device Publish Date: 2019-10-03

Devices Manufactured by OWEN MUMFORD LIMITED

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• 00384701614033 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm
• 00384701634031 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 25G x 1.6mm
• 00384701644030 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 28G x 1.2mm
• 00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm: 2021-04-12 Sterile, single use safety lancet
• 00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm: 2021-04-12 Sterile, single use safety lancet