gudid
Primary ID: TEF-002
Cytoflex Smooth Tef-Guard (UDI TEF-002)
Manufactured by UNICARE BIOMEDICAL INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Cytoflex Smooth Tef-Guard - Primary ID TEF-002
Device Regulatory Overview
The Cytoflex Smooth Tef-Guard (Model/Catalog Number: TEF-002) 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
- TEF-002
- Product Code / EMDN
- NPK
- Device Name
- Cytoflex Tef-Guard is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex Tef-Guard has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex Tef-Guard is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.
- 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
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Cytoflex Smooth Tef-Guard?
The registered manufacturer of record for Cytoflex Smooth Tef-Guard is UNICARE BIOMEDICAL INC..
What is the Primary UDI-DI identifier for Cytoflex Smooth Tef-Guard?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TEF-002.
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.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint