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US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(760)743-7744
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 601302743
Catalogue (260)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aria | 89358 | FDA UDI | Class II | Active |
| First Quarter | 90811 | FDA UDI | Class II | Active |
| Turbo Temp 3 | 93323 | FDA UDI | Class II | Active |
| Contact Matrix | 89434 | FDA UDI | Class I | Active |
| Aria | 89360 | FDA UDI | Class II | Active |
| Startflow | 85053 | FDA UDI | Class II | Active |
| Fusion | FTXBL | FDA UDI | Class II | Active |
| First Half | 93133 | FDA UDI | Class II | Active |
| Startflow | 85071 | FDA UDI | Class II | Active |
| Accolade | 90546 | FDA UDI | Class II | Active |
| Start Vps | 80007-01 | FDA UDI | Class II | Active |
| Pontic | 90133 | FDA UDI | Class II | Active |
| Startflow | 89039 | FDA UDI | Class II | Active |
| Startflow | 85058 | FDA UDI | Class II | Active |
| Rock Core | 92169 | FDA UDI | Class II | Active |
| Startflow | 89475 | FDA UDI | Class II | Active |
| Start Vps | 93354 | FDA UDI | Class II | Active |
| Prelude | 90976 | FDA UDI | Class II | Active |
| Prelude | 91024 | FDA UDI | Class II | Active |
| Microprophy | 201684-00 | FDA UDI | Class I | Active |
| First Half | 91123 | FDA UDI | Class II | Active |
| Accolade | 90554 | FDA UDI | Class II | Active |
| Turbo Temp 3 | 93326 | FDA UDI | Class II | Active |
| Start Vps | 93352 | FDA UDI | Class II | Active |
| Startflow | 89466 | FDA UDI | Class II | Active |
| Accolade Sro | 93829 | FDA UDI | Class II | Active |
| Startflow | 89469 | FDA UDI | Class II | Active |
| Bulk Ez | 94776 | FDA UDI | Class II | Active |
| Contact Matrix | 91475 | FDA UDI | Class I | Active |
| First Quarter | 89462 | FDA UDI | Class II | Active |
| Accolade Pv | 90562 | FDA UDI | Class II | Active |
| Microetcher | 21000-03 | FDA UDI | Class II | Active |
| Viax | 94973 | FDA UDI | Class II | Active |
| Startflow | 89472 | FDA UDI | Class II | Active |
| Accolade Pv | 91238 | FDA UDI | Class II | Active |
| Sky Select | KY9021 | FDA UDI | Class II | Active |
| Startflow | 89468 | FDA UDI | Class II | Active |
| Startflow | 89041 | FDA UDI | Class II | Active |
| Start Vps | 80024-01 | FDA UDI | Class II | Active |
| Turbo Temp 3 | 93591 | FDA UDI | Class II | Active |
| Start Vps | 80016 | FDA UDI | Class II | Active |
| First Quarter | 90902 | FDA UDI | Class II | Active |
| Startflow | 89465 | FDA UDI | Class II | Active |
| Accolade Op | 93598 | FDA UDI | Class II | Active |
| First Half | 91242 | FDA UDI | Class II | Active |
| Accolade | 90553 | FDA UDI | Class II | Active |
| Royal | 81002 | FDA UDI | Class II | Active |
| Turbo Temp 2 | 90344 | FDA UDI | Class II | Active |
| Bulk Ez | 94778 | FDA UDI | Class II | Active |
| Sky Select | KY9031 | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 24, 2016 | Z-2530-2016 | — | terminated | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim. |