AccessGUDID - DEVICE: M&S Technologies Clinical Trial Suite® (00850040295139)

GUDID

Device Identifier (DI) Information

Brand Name: M&S Technologies Clinical Trial Suite®
Version or Model: CTS-1500-HR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Hilsinger Company Parent LLC

Primary DI Number: 00850040295139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118021111 *Terms of Use

Device Description: M&S Technologies Clinical Trial Suite®

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?
35922	Visual acuity projector	A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTO	Digital Visual Acuity Test

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: 1500913e-a973-49d4-92aa-f4f9adee366b
Public Version Date: December 21, 2023
Public Version Number: 4
DI Record Publish Date: July 06, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00850040295009	1	00850040295139	In Commercial Distribution	CTS-VACAL
00850040295153	1	00850040295139	In Commercial Distribution	CTS-EVAH
00850040295160	1	00850040295139	In Commercial Distribution	CTS-DVA5000
00850040295757	1	00850040295139	In Commercial Distribution	CTS-RTK-0155
00850040295764	1	00850040295139	In Commercial Distribution	CTS-EVA-DRCR
00850040295771	1	00850040295139	In Commercial Distribution	CTS-ATS-PEDIG