FDA UDI In Commercial Distribution 🇺🇸 United States

LOTTA

DI: 04048551279663 · Model: 28164LLA · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LOTTA
Primary DI
04048551279663
Version / Model
28164LLA
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
6
Public Version Date
2023-11-03
Public Version Status
Update
Public Device Record Key
b36a6f33-922f-4f03-bad3-6da113dd8d73

Device Description

Little LOTTA Ventriculoscope

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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
GWG ENDOSCOPE, NEUROLOGICAL

GMDN Terms

Code Name
36904 Rigid optical intracranial/spinal endoscope, reusable

Identifiers

Type ID
Primary 04048551279663

Premarket Submissions

Submission Number Supplement Number
K982837 000