AccessGUDID - DEVICE: 4K CAMERA HEAD (04953170374609)

GUDID

Device Identifier (DI) Information

Brand Name: 4K CAMERA HEAD
Version or Model: OLYMPUS CH-S400-XZ-EB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170374609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
FET	Endoscopic video imaging system/component, gastroenterology-urology
GCJ	Laparoscope, general & plastic surgery
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
FGB	Ureteroscope and accessories, flexible/rigid
NWB	Endoscope, accessories, narrow band spectrum
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172817	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 992c3a64-9e0f-440c-8eb7-fc39818d0917
Public Version Date: April 22, 2024
Public Version Number: 8
DI Record Publish Date: September 21, 2016