DEVICE: HOPKINS (04048551097694)

Device Identifier (DI) Information

HOPKINS
28162AKA
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551097694
GS1

1
315731430 *Terms of Use
HOPKINS® Telescope 0°, 2.7 mm, 20 cm
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rigid neuroscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the central nervous system (CNS). It is inserted into the body through a pre-drilled hole in the cranium for neuroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GWG ENDOSCOPE, NEUROLOGICAL
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
Hydrogen Peroxide
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f86d1302-6c0c-41c2-b220-04beb7b94890
March 29, 2018
2
September 23, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE