Leica Microscope Cover W/Angle Lens 54” x 149” (137cm X 380cm)

Basic Information

• Brand Name: Leica Microscope Cover W/Angle Lens 54” x 149” (137cm X 380cm)
• Primary DI: 00836230000721
• Version / Model: VMD80-5449
• Company Name: PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
• Labeler DUNS: 532186541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-17
• Public Version: 1
• Public Version Date: 2022-11-25
• Public Version Status: New
• Public Device Record Key: 329b9f5e-35a3-4c11-9eb1-7bcfc04440a3

Device Description

Medical equipment drape, single-use

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	01836230000720	GS1	box	5	In Commercial Distribution
Primary	00836230000721	GS1
Package	02836230000729	GS1	box	5	In Commercial Distribution