AccessGUDID - DEVICE: Aligned Medical Solutions (B098DDS1159A0)

GUDID

Device Identifier (DI) Information

Brand Name: Aligned Medical Solutions
Version or Model: DDS1159A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DDS1159A
Company Name: Aligned Medical Solutions

Primary DI Number: B098DDS1159A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106580145 *Terms of Use

Device Description: HEART CATH TRAY-RX

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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
OES	Cardiac Catheterization Kit

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
Handling Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53dc0aae-79b1-46fa-99c8-c33da4d29bdf
Public Version Date: January 04, 2024
Public Version Number: 1
DI Record Publish Date: December 27, 2023