Digitimer

GUDID 05060490360010

DIGITIMER LIMITED

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: 05060490360010
• NIH Device Record Key: c16100c5-84a0-4fc9-bc77-6b86510f5167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digitimer
• Version Model Number: DS7AH
• Company DUNS: 211220892
• Company Name: DIGITIMER LIMITED
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060490360010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051357

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2023-09-29
• Device Publish Date: 2023-09-21

On-Brand Devices [Digitimer]

• 05060490360058: DS7AP
• 05060490360041: D185
• 05060490360010: DS7AH
• 05060490360003: DS7A