OPTIBAG SIZE 3 200PCS

Basic Information

• Brand Name: OPTIBAG SIZE 3 200PCS
• Primary DI: 06430035873159
• Version / Model: 900186
• Company Name: PaloDEx Group Oy
• Labeler DUNS: 459955188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-01
• Public Version: 1
• Public Version Date: 2020-02-10
• Public Version Status: New
• Public Device Record Key: 92fa3ae7-5413-4728-a585-b04c6b8be935

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: No
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63712	Medical equipment drape, single-use, non-sterile	A non-sterile 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 not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430035873159	GS1

Premarket Submissions

Submission Number	Supplement Number
K133231	000