UDI device identifier
MENTOR Smooth Round SPECTRUM 3501470
UDI device identifier 00081317002017 · MENTOR TEXAS L.P.
Key facts
| Primary DI | 00081317002017 |
|---|---|
| Brand name | MENTOR Smooth Round SPECTRUM |
| Version or model | 3501470 |
| Catalog number | 350-1470 |
| Company | MENTOR TEXAS L.P. |
| DUNS number | 167450993 |
| Product code | FWM |
| GMDN term | Saline-filled breast implant, unstructured, smooth-surface |
| Premarket submission | P990075 |
| Device class | Class III |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | Yes |
| Publish date | Sep 17, 2014 |
| Version date | Feb 11, 2021 |
| Description | Post Operatively Adjustable Saline Breast Implant, 425cc |Smooth|Round|Saline| |
At a glance
- 100–999 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: