DEVICE: HOPKINS (04048551094549)
Device Identifier (DI) Information
HOPKINS
28132FVA
In Commercial Distribution
Karl Storz GmbH & Co. KG
28132FVA
In Commercial Distribution
Karl Storz GmbH & Co. KG
HOPKINS® Telescope 45°, 4 mm, 18 cm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36904 | Rigid optical intracranial/spinal endoscope, reusable |
An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle; it does not include video imaging capability, however, might be used with a separate video camera for optional video image viewing. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GWG | ENDOSCOPE, NEUROLOGICAL |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K982837 | 000 |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Moist Heat or Steam Sterilization |
| Hydrogen Peroxide |
| Ethylene Oxide |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
0f3188fa-91e4-4b59-b4d7-6e6652058b7c
November 03, 2023
6
September 23, 2016
November 03, 2023
6
September 23, 2016
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined