FDA UDI In Commercial Distribution 🇺🇸 United States

URETERO-RENO FIBERSCOPE

DI: 04953170403811 · Model: OLYMPUS URF-P7 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
URETERO-RENO FIBERSCOPE
Primary DI
04953170403811
Version / Model
OLYMPUS URF-P7
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-02-11
Public Version
3
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
f83cc114-80f0-4189-9457-c6a3624d06ce

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
["Ethylene Oxide", "Hydrogen Peroxide"]

Product Codes

Code Name
NWB Endoscope, accessories, narrow band spectrum
FBN Choledochoscope and accessories, flexible/rigid
FGB Ureteroscope and accessories, flexible/rigid

GMDN Terms

Code Name
37111 Flexible fibreoptic ureterorenoscope

Identifiers

Type ID
Primary 04953170403811

Customer Contacts