FDA UDI
In Commercial Distribution
🇺🇸 United States
M&S Technologies Smart System® Standard
DI: 00850040295559
·
Model: Smart System Standard
·
The Hilsinger Company Parent LLC
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- M&S Technologies Smart System® Standard
- Primary DI
- 00850040295559
- Version / Model
- Smart System Standard
- Company Name
- The Hilsinger Company Parent LLC
- Labeler DUNS
- 118021111
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-06
- Public Version
- 3
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- c3652316-e327-456c-9a07-3f870764f5cd
Device Description
M&S Technologies Smart System® Standard
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QTO | Digital Visual Acuity Test | Ophthalmic | 886.1150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850040295559 | GS1 | ||||
| Package | 00850040295085 | GS1 | SS-STD | 1 | In Commercial Distribution | |
| Package | 00850040295467 | GS1 | SS-STD-PC-SFT | 1 | In Commercial Distribution | |
| Package | 00850040295481 | GS1 | SS-STD-MAC-SFT | 1 | In Commercial Distribution | |
| Package | 00850040295498 | GS1 | SS-STD-PC-SFTi | 1 | In Commercial Distribution | |
| Package | 00850040295689 | GS1 | R-AIO-STD-UPG | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-877-225-6101
- [email protected]