UDI device identifier
MENTOR CPX 2 Breast Tissue Expander 3546214
UDI device identifier 00081317002277 · MENTOR TEXAS L.P.
Key facts
| Primary DI | 00081317002277 |
|---|---|
| Brand name | MENTOR CPX 2 Breast Tissue Expander |
| Version or model | 3546214 |
| Catalog number | 354-6214 |
| Company | MENTOR TEXAS L.P. |
| DUNS number | 167450993 |
| Product code | LCJ |
| GMDN term | Skin-port tissue expander |
| Premarket submission | K011500 |
| Device class | Unclassified |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | Yes |
| Publish date | Sep 7, 2015 |
| Version date | Feb 11, 2021 |
| Description | SITLEX Medium Height Tissue Expander Style 6200, 550cc |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ 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: