AutoLap PU

Basic Information

• Brand Name: AutoLap PU
• Primary DI: 07290016648010
• Version / Model: ASS06008US
• Company Name: M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
• Labeler DUNS: 649827193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8d378a53-5a6e-4224-bb51-b53f33ca7a1d

Device Description

Processing Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16240	Laparoscope holder	A device intended to be used to hold, maintain in a desired position, and allow positional adjustment of, a laparoscope and associated instruments/devices during laparoscopy; it may also be intended to hold/position other surgical devices (e.g., retractors, manipulators) during other endoscopic or open surgical procedures. It typically consists of joints, rigid or semi-rigid arms, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016648010	GS1
Package	17290016648017	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K131375	000
K152848	000