AccessGUDID - DEVICE: ACIST HDi® Linear Translation System (LTS) (10841716100694)

GUDID

Device Identifier (DI) Information

Brand Name: ACIST HDi® Linear Translation System (LTS)
Version or Model: 017988
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ACIST MEDICAL SYSTEMS, INC.

Primary DI Number: 10841716100694
Issuing Agency: GS1
Commercial Distribution End Date: January 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 926684994 *Terms of Use

Device Description: HDi LTS, p/n 701457-004

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?
40763	Cardiovascular ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBJ	Catheter, Ultrasound, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 5b9c46c6-50ca-4c0e-891a-46391e1eb60b
Public Version Date: May 09, 2024
Public Version Number: 3
DI Record Publish Date: February 17, 2017