FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551007617 · Model: 28162AMA · 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
04048551007617
Version / Model
28162AMA
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
cbe73cd4-f285-4493-9d56-5791709cb572

Device Description

Gaab Neuroscope 6° autoclaveable

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
["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
GWG ENDOSCOPE, NEUROLOGICAL

GMDN Terms

Code Name
36904 Rigid optical intracranial/spinal endoscope, reusable

Identifiers

Type ID
Primary 04048551007617

Premarket Submissions

Submission Number Supplement Number
K982837 000