FDA UDI In Commercial Distribution 🇺🇸 United States

Synaptix Plug B Type

DI: 08055713177046 · Model: DWS-B1J000000W · MEDICAL MICROINSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Synaptix Plug B Type
Primary DI
08055713177046
Version / Model
DWS-B1J000000W
Company Name
MEDICAL MICROINSTRUMENTS, INC.
Labeler DUNS
435958412
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-06
Public Version
1
Public Version Date
2026-03-16
Public Version Status
New
Public Device Record Key
6b52a47d-b543-436f-8f68-70eb4c053f64

Device Description

An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
SAQ Electromechanical System For Open Microsurgery

GMDN Terms

Code Name
36612 Image display unit, colour

Identifiers

Type ID
Primary 08055713177046

Premarket Submissions

Submission Number Supplement Number
K251510 000