Neuropen

GUDID 00384700100032

Non sterile, sensory neuropathy screening device

OWEN MUMFORD LIMITED

Pressure algometer/aesthesiometer, mechanical

• Primary Device ID: 00384700100032
• NIH Device Record Key: 740713d5-5237-42a2-be4e-7f02a5fe820c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuropen
• Version Model Number: NT0100
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD 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: false
• 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: 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	00384700100018 [Primary]
GS1	00384700100032 [Package]; Contains: 00384700100018; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• GXB: Esthesiometer

Sterilization

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

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

• 00384701402036 - Unistik Touch: 2023-04-07 Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
• 00384701015038 - Unistik: 2023-02-15 Unistik Safety Lancet Economy - 21G
• 00384701027024 - Unistik 3: 2023-02-15 Unistik 3 Safety Lancet Gentle - 30G
• 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