AutoLap Sterile Drape

GUDID 07290016648331

M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

Surgical instrument assist arm system, power-adjusted

• Primary Device ID: 07290016648331
• NIH Device Record Key: 1d82ee74-c42d-4ac0-8581-457087624c91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoLap Sterile Drape
• Version Model Number: ASS07022US
• Company DUNS: 649827193
• Company Name: M.S.T. MEDICAL SURGERY TECHNOLOGIES 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	07290016648331 [Primary]
GS1	17290016648338 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131375

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-02-13

On-Brand Devices [AutoLap Sterile Drape]

• 07290016648331: ASS07022US
• 17290016648246: ASS07018US