Cadwell

GUDID 26955739013150

Xi'an Friendship Medical Electronics Co.,Ltd.

Subdermal needle electrode Subdermal needle electrode

• Primary Device ID: 26955739013150
• NIH Device Record Key: 933676cd-f86e-4db9-8459-b0fb4c81b47a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell
• Version Model Number: 302822-000-100
• Company DUNS: 529249095
• Company Name: Xi'an Friendship Medical Electronics Co.,Ltd.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16955739013153 [Primary]
GS1	26955739013150 [Package]; Contains: 16955739013153; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072276

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

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

[26955739013150]

Ethylene Oxide

[26955739013150]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-31