FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048438005408 · Model: 011160-10 · Karl Storz GmbH & Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
n.a.
Primary DI
04048438005408
Version / Model
011160-10
Catalog Number
011160-10
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2024-10-04
Public Version
2
Public Version Date
2024-10-21
Public Version Status
Update
Public Device Record Key
79c971b0-f4af-40e1-a08a-5d5171fb14d5

Device Description

Electrode, bipolar

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
No
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
FAS ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIH HYSTEROSCOPE (AND ACCESSORIES)
FJL Resectoscope
FDC Resectoscope, working element

GMDN Terms

Code Name
61872 Endoscopic electrosurgical electrode, bipolar, single-use

Identifiers

Type ID
Unit of Use 04048438005392
Primary 04048438005408