FDA UDI In Commercial Distribution 🇺🇸 United States

EVIS EXERA lll COLONOVIDEOSCOPE

DI: 04953170305115 · Model: OLYMPUS CF-HQ190L · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EVIS EXERA lll COLONOVIDEOSCOPE
Primary DI
04953170305115
Version / Model
OLYMPUS CF-HQ190L
Catalog Number
N3802140
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
6
Public Version Date
2023-12-27
Public Version Status
Update
Public Device Record Key
021bed89-5480-427d-b2d1-a5da08e909a5

Device Description

CF-HQ190L EVIS EXERA III HD COLONOSCOPE

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["High-level Disinfectant", "Ethylene Oxide"]

Product Codes

Code Name
FDF Colonoscope and accessories, flexible/rigid
FDS Gastroscope And Accessories, Flexible/Rigid
NWB Endoscope, Accessories, Narrow Band Spectrum

GMDN Terms

Code Name
36117 Flexible video colonoscope, reusable

Identifiers

Type ID
Primary 04953170305115

Customer Contacts