LawMax Dilator

GUDID 06938370131526

Lifetech Scientific (Shenzhen) Co., Ltd.

Vascular dilator, single-use

• Primary Device ID: 06938370131526
• NIH Device Record Key: 0f31f65a-cbe8-429d-ad95-25085977e139
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LawMax Dilator
• Version Model Number: LT-DIL-16F
• Company DUNS: 529864170
• Company Name: Lifetech Scientific (Shenzhen) 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938370131526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123842

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-17

On-Brand Devices [LawMax Dilator]

• 06938370131564: LT-DIL-24F
• 06938370131557: LT-DIL-22F
• 06938370131540: LT-DIL-20F
• 06938370131533: LT-DIL-18F
• 06938370131526: LT-DIL-16F
• 06938370131519: LT-DIL-14F