FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551169629 · Model: 496U · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
n.a.
Primary DI
04048551169629
Version / Model
496U
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-24
Public Version
2
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
f180cab5-36df-46be-9847-8df90828c903

Device Description

Fiber Optic Ureter Probe

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ethylene Oxide", "Liquid Chemical"]

Product Codes

Code Name
FCS Light, catheter, fiberoptic, glass, ureteral

GMDN Terms

Code Name
41605 Ureteral transilluminator, reusable

Identifiers

Type ID
Primary 04048551169629