AccessGUDID - DEVICE: On-X Heart Valve Instruments (00851788001747)

GUDID

Device Identifier (DI) Information

Brand Name: On-X Heart Valve Instruments
Version or Model: ONXI3-CT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ONXI3-CT
Company Name: ON-X LIFE TECHNOLOGIES, INC.

Primary DI Number: 00851788001747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844782318 *Terms of Use

Device Description: The instrument tray (Gold) is optional and may be used for storage and transportation of On-X® Heart Valve instruments. The tray can withstand steam sterilization and instruments may be sterilized in this tray.

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?
12143	Instrument tray, reusable	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 might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFA	Cardiovascular Surgical Instruments 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: stored in a clean, cool and dry environment.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fbda8953-4005-435d-ab35-96d90ebbfca8
Public Version Date: August 17, 2023
Public Version Number: 1
DI Record Publish Date: August 09, 2023