Cytoflex Tefguard Ti-Enforced Membrane
Unicare Biomedical, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2032542 | 3003646540 | UNICARE BIOMEDICAL, INC. | 1 | N | 2026-01-01 | 23011 Moulton Pkwy Ste J11 Laguna Hills CA US 92653 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| D767C0635010 | Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures. | 949-305-9600 | sales@unicarebiomedical.com |
| D767C0639010 | Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures. | 949-305-9600 | sales@unicarebiomedical.com |
| D767C0641010 | Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures. | 949-305-9600 | sales@unicarebiomedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 55158 | 1660920284 | K200623 | OssGuide | NPL | 2020-10-02 |
| 55158 | 1990310161 | K151344 | Cytoflex Tefguard Ti-Enforced Membrane | NPK | 2015-11-19 |
| 55158 | 1986655315 | K100927 | SURGIAID | KGN | 2011-02-02 |
| 55158 | 1588460234 | K092567 | MODIFICATION TO UNIGRAFT | LYC | 2009-11-25 |
| 55158 | 1028016369 | K090612 | BENACEL | OLR | 2009-07-24 |
| 55158 | 1480571649 | K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | LYC | 2009-03-23 |
| 55158 | 1167418266 | K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | QSY | 2008-11-12 |
| 55158 | 1139061752 | K021511 | CYTOFLEX MESH | JEY | 2002-08-06 |
| 55158 | 1508394006 | K012144 | CYTOFLEX | LYC | 2001-10-01 |
Unicare Biomedical, Inc.
UNICARE BIOMEDICAL, INC.
UNICARE BIOMEDICAL
UNICARE BIOMEDICAL, INC.
UNICARE BIOMEDICAL, INC.
UNICARE BIOMEDICAL, INC.
UNICARE BIOMEDICAL, INC.
UNICARE BIOMEDICAL
UNICARE BIOMEDICAL
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