FDA UDI In Commercial Distribution 🇺🇸 United States

HOPKINS

DI: 04048551091432 · Model: 28007AA · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HOPKINS
Primary DI
04048551091432
Version / Model
28007AA
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
c1f4c540-b4f0-4255-acef-0df57712b6d5

Device Description

HOPKINS® Telescope 0°, 3.3 mm, 25 cm

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

Product Codes

Code Name
GWG ENDOSCOPE, NEUROLOGICAL

GMDN Terms

Code Name
36904 Rigid optical intracranial/spinal endoscope, reusable

Identifiers

Type ID
Primary 04048551091432

Premarket Submissions

Submission Number Supplement Number
K982837 000