AutoLap PU

GUDID 07290016648010

Processing Unit

M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

Laparoscope holder

• Primary Device ID: 07290016648010
• NIH Device Record Key: 8d378a53-5a6e-4224-bb51-b53f33ca7a1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoLap PU
• Version Model Number: ASS06008US
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07290016648010 [Primary]
GS1	17290016648017 [Package]; Package: [1 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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

• 17290016648079 - AutoLap ARM Unit Package: 2019-03-11
• 17290016648246 - AutoLap Sterile Drape: 2019-03-11
• 07290016648027 - AutoLap ARM: 2019-03-11
• 07290016648034 - AutoLap Curved ARM: 2019-03-11
• 07290016648058 - AutoLap Cart: 2019-03-11
• 07290016648072 - AutoLap ARM Unit: 2019-03-11
• 07290016648089 - AutoLap Bar: 2019-03-11
• 07290016648096 - AutoLap Curved Bar: 2019-03-11