Greentek

GUDID 06970295340003

Wuhan Greentek Pty Ltd.

Electroencephalographic electrode cap, single-use

• Primary Device ID: 06970295340003
• NIH Device Record Key: 32629b2b-4a33-40cf-b42b-83703ba45228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Greentek
• Version Model Number: Flex-Cap BM-FA01-23ST
• Company DUNS: 530267329
• Company Name: Wuhan Greentek Pty Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970295340003 [Primary]
GS1	06970295340065 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200162

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: 2021-07-28
• Device Publish Date: 2021-07-20

On-Brand Devices [Greentek]

• 06970295340003: Flex-Cap BM-FA01-23ST
• 06970295340041: Flex-Cap BM-FC01-23ST
• 06970295340010: AM-MD15-23ST
• 06970295340690: AM-MD15-13C1
• 06970295340683: AM-MD15-23C1
• 06970295340676: Flex-cap BM-FN03-13C1
• 06970295340669: Flex-cap BM-FC03-23C1
• 06970295340652: Flex-cap BM-FA03-23C1