Silver-Thera Sock

GUDID B872STS33130

Silver-Thera Sock

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B872STS33130
• NIH Device Record Key: 37f753ad-41d7-41af-8185-1f81ef450aac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silver-Thera Sock
• Version Model Number: STS3313
• Company DUNS: 790271118
• Company Name: PRIZM MEDICAL, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	B872STS33130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944487

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [Silver-Thera Sock]

• B872STS33150: Silver-Thera Sock - XL
• B872STS33140: Silver-Thera Sock - Large
• B872STS33130: Silver-Thera Sock