gudid
Primary ID: 25x30mm
Cytoflex Ti-enforced (UDI 25x30mm)
Manufactured by UNICARE BIOMEDICAL INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Cytoflex Ti-enforced - Primary ID 25x30mm
Device Regulatory Overview
The Cytoflex Ti-enforced (Model/Catalog Number: 25x30mm) is a medical device manufactured by UNICARE BIOMEDICAL INC.. This product is indexed under FDA Product Code / Category Classification NPK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 25x30mm
- Product Code / EMDN
- NPK
- Device Name
- Ti-Enforced ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.
- Database Sync Date
- 2026-08-09 09:14:58
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Cytoflex Ti-enforced?
The registered manufacturer of record for Cytoflex Ti-enforced is UNICARE BIOMEDICAL INC..
What is the Primary UDI-DI identifier for Cytoflex Ti-enforced?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 25x30mm.
What classification code is assigned to this device?
This device is registered under product classification code NPK.
Similar Classification Devices (NPK)
Other Devices by UNICARE BIOMEDICAL INC.
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