AccessGUDID - DEVICE: Medical Action Industries (10809160020395)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 74657
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 10809160020395
Issuing Agency: GS1
Commercial Distribution End Date: February 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46408	Cardiothoracic surgical procedure kit, medicated, single-use	A collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: store at room temperature
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10a10296-b627-43da-944d-7db98dd5607d
Public Version Date: March 11, 2019
Public Version Number: 3
DI Record Publish Date: August 20, 2016