GTK

GUDID 06937845500614

Guangzhou T.K Medical Instrument Co.,Ltd.

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 06937845500614
• NIH Device Record Key: e7dd1136-0b76-4dfa-bdcc-28dce83f3d3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GTK
• Version Model Number: VN-150
• Company DUNS: 546374737
• Company Name: Guangzhou T.K Medical Instrument 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06937845500614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193339

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

On-Brand Devices [GTK]

• 06937845500614: VN-150
• 06937845500607: VN-120