AccessGUDID - DEVICE: ZEOS (00812231030363)

GUDID

Device Identifier (DI) Information

Brand Name: ZEOS
Version or Model: 84-20-50032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 84-20-50032
Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.

Primary DI Number: 00812231030363
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065016344 *Terms of Use

Device Description: ACMI LIGHT GUIDE POST ADAPTER

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?
46113	Endoscopic light source adaptor	A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope

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

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: 44a43dd3-5f88-450c-91f9-25cc8c0884d0
Public Version Date: October 01, 2018
Public Version Number: 1
DI Record Publish Date: August 30, 2018