AccessGUDID - DEVICE: AED 25MM Optical Coupler (00848657084772)

GUDID

Device Identifier (DI) Information

Brand Name: AED 25MM Optical Coupler
Version or Model: CPL 25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CPL 25
Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Primary DI Number: 00848657084772
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839138955 *Terms of Use

Device Description: Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

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?
36292	Endoscope camera adaptor	An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
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: 89a65c24-92e4-48ac-a77e-c7239175b41e
Public Version Date: March 19, 2021
Public Version Number: 2
DI Record Publish Date: March 06, 2020