FDA UDI In Commercial Distribution 🇺🇸 United States

EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

DI: 04953170202247 · Model: OLYMPUS GIF TYPE Q180 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
Primary DI
04953170202247
Version / Model
OLYMPUS GIF TYPE Q180
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
5
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
82525896-0cc5-4dc6-8e37-4fa1795fe252

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
Yes
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
NWB Endoscope, accessories, narrow band spectrum
FDS Gastroscope and accessories, flexible/rigid
FDF Colonoscope and accessories, flexible/rigid

GMDN Terms

Code Name
38805 Flexible video gastroduodenoscope

Identifiers

Type ID
Primary 04953170202247

Customer Contacts