FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551259191 · Model: 20535280 · 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
04048551259191
Version / Model
20535280
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
2016-09-23
Public Version
4
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
3dc83244-1b04-4ea1-a6dc-785eb16a2cbb

Device Description

Auxiliary Module Resection

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
11490 Electrosurgical system generator

Identifiers

Type ID
Primary 04048551259191

Premarket Submissions

Submission Number Supplement Number
K062464 000