AccessGUDID - DEVICE: Oasis Biodegradable Tray (00843356102345)

GUDID

Device Identifier (DI) Information

Brand Name: Oasis Biodegradable Tray
Version or Model: OT1430
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356102345
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: Oasis Biodegradable Tray with center reservoir and reversible four tab lid. Constructed with virgin biodegradable fiber - 30 trays & 30 lids

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:	Yes
Prescription Use (Rx):	No
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?
47081	Endoscope transport trolley tray	A support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PXV	General Purpose Instrument Tray

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 7de649d8-8c89-4cf9-9ed7-9e54f0a42924
Public Version Date: October 02, 2020
Public Version Number: 1
DI Record Publish Date: September 24, 2020