AutoLap Sterile Components Kit Package- Clip, 10mm

GUDID 27290016648311

The kit Contains: 1X Clip units box (6 Clip units/box), 3X 10mm Clippers set box (2 sets/box)

M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

Laparoscope holder Laparoscope holder

• Primary Device ID: 27290016648311
• NIH Device Record Key: c361e8e6-b6ca-4b49-be85-93a21d8bf9fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoLap Sterile Components Kit Package- Clip, 10mm
• Version Model Number: ASS02430US
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	27290016648311 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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

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• 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