AutoLap ARM Unit Package

Basic Information

• Brand Name: AutoLap ARM Unit Package
• Primary DI: 17290016648079
• Version / Model: ASS06030
• 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: 2017-01-19
• Public Version: 4
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 8d20a8ff-3948-4311-81ba-2a67182ac4e2

Device Characteristics

• Single Use: Yes
• 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: No
• 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
62380	Surgical instrument assist arm system, power-adjusted	A device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290016648079	GS1

Premarket Submissions

Submission Number	Supplement Number
K131375	000
K152848	000