| Primary Device ID | 00620974004288 |
| NIH Device Record Key | b19ed9d8-8a62-4613-9cec-b9043cf0e30b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BetterShield |
| Version Model Number | MXFS-40-FOAM |
| Catalog Number | MXFS-40-FOAM |
| Company DUNS | 246848147 |
| Company Name | Southmedic Incorporated |
| Device Count | 40 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com | |
| Phone | +1(705)726-9383 |
| custserv@southmedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00620974004288 [Unit of Use] |
| GS1 | 10620974004285 [Primary] |
| HOY | Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-29 |
| Device Publish Date | 2025-12-19 |
| 00620974004288 - BetterShield | 2025-12-29Foam Face Shield |
| 00620974004288 - BetterShield | 2025-12-29 Foam Face Shield |
| 00620974004325 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 2 mm |
| 00620974004332 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 3 mm |
| 00620974004349 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 4 mm |
| 00620974004356 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 5 mm |
| 00620974004363 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 6 mm |
| 00620974004370 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Twisted wire brush 18" 20 mm |
| 00620974004387 - Southmedic Instrument Cleaning Brushes | 2025-09-05 Brush Toothbrush style, extra firm, double end, Nylon, 7" |