DEVICE: TRICAM® (04048551064092)
Device Identifier (DI) Information
TRICAM®
20221139
In Commercial Distribution
20221139
Karl Storz GmbH & Co. KG
20221139
In Commercial Distribution
20221139
Karl Storz GmbH & Co. KG
TRICAM-P PDD/AF Camera Head NTSC
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? |
---|---|---|---|---|
35958 | Endoscope video camera |
An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAY | Light Source System, Diagnostic Endoscopic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P050027 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b6fac602-216f-4d35-8d7f-baddd3ef3ac1
October 24, 2022
6
September 24, 2014
October 24, 2022
6
September 24, 2014
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
[?]
+14242188201
regulatory@karlstorz.com
regulatory@karlstorz.com