CeroFrict

Basic Information

• Brand Name: CeroFrict
• Primary DI: 04897129990109
• Version / Model: SML007-TP01
• Company Name: SML Med-Tech Solutions Limited
• Labeler DUNS: 687239367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 1
• Public Version Date: 2023-05-15
• Public Version Status: New
• Public Device Record Key: 441c2ccc-5b51-44d6-a1ce-fe97af2196cc

Device Description

Disposable Endoscope Tip Protector

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: No
• 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
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64018	Instrument hygienic-transportation bag	A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/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	14897129990106	GS1		75	In Commercial Distribution
Primary	04897129990109	GS1
Package	24897129990103	GS1		4	In Commercial Distribution