AccessGUDID - DEVICE: Oasis Biodegradable Scope Transport Tray (00843356100631)

GUDID

Device Identifier (DI) Information

Brand Name: Oasis Biodegradable Scope Transport Tray
Version or Model: OT1530
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356100631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: Oasis Biodegradable Scope Transport Tray with clean/soiled reversible four tab lid, made with virgin pulp - 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?
65161	Instrument tray, single-use	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure. It is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device.	Active	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: 22fa3777-abae-4cba-8b0a-15041c124daa
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: November 30, 2021