FDA UDI In Commercial Distribution 🇺🇸 United States

HOPKINS

DI: 04048551115060 · Model: 28730BA · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HOPKINS
Primary DI
04048551115060
Version / Model
28730BA
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
5a1a7800-1849-47d1-803f-d789a432d65b

Device Description

HOPKINS® Telescope 30°, 4 mm, 9.5 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
Moist Heat or Steam Sterilization

Product Codes

Code Name
HRX ARTHROSCOPE

GMDN Terms

Code Name
36904 Rigid optical intracranial/spinal endoscope, reusable

Identifiers

Type ID
Primary 04048551115060

Premarket Submissions

Submission Number Supplement Number
K943052 000