OPMI® Drapes sterile

Basic Information

• Brand Name: OPMI® Drapes sterile
• Primary DI: 04049539101297
• Version / Model: 326082-0000-000
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 342228620
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b894cc68-6a5b-4a71-bb20-ce0d7de2b2e5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45021	Instrument/equipment drape, single-use, sterile	A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04049539102294	GS1		10	In Commercial Distribution
Package	04049539102089	GS1		10	In Commercial Distribution
Primary	04049539101297	GS1

Device Sizes

Type	Value	Unit	Text
Height	13	Inch
Width	14.25	Inch
Height	33	Centimeter
Width	36	Centimeter