Single Use Guiding Device

Basic Information

• Brand Name: Single Use Guiding Device
• Primary DI: 04953170406171
• Version / Model: CC-220DR
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-07
• Public Version: 3
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: ccb7ec2b-83a1-46e9-a564-7febddef2935

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BTG	Brush, biopsy, bronchoscope (non-rigid)	Ear, Nose, Throat	874.4680	2
EOQ	Bronchoscope (flexible or rigid)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65401	Bronchoscopic biopsy curette, flexible, single-use	A flexible device intended to be used through a flexible bronchoscope to obtain specimens of the bronchi for histological/pathological diagnosis during bronchoscopy. It is a type of biopsy forceps whose flexible insertion portion is made of a metal coil or a plastic tube, but where at the distal end terminates in a sharply-pointed scoop/receptacle for securing the biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170406178	GS1		1	In Commercial Distribution
Primary	04953170406171	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]