gudid
Primary ID: 200-400um 0.4g
Unigraft (UDI 200-400um 0.4g)
Manufactured by UNICARE BIOMEDICAL INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unigraft - Primary ID 200-400um 0.4g
Device Regulatory Overview
The Unigraft (Model/Catalog Number: 200-400um 0.4g) is a medical device manufactured by UNICARE BIOMEDICAL INC.. This product is indexed under FDA Product Code / Category Classification LYC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 200-400um 0.4g
- Product Code / EMDN
- LYC
- Device Name
- Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.
- Database Sync Date
- 2026-08-09 09:14:58
Full Regulatory Attributes
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{
"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 Unigraft?
The registered manufacturer of record for Unigraft is UNICARE BIOMEDICAL INC..
What is the Primary UDI-DI identifier for Unigraft?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 200-400um 0.4g.
What classification code is assigned to this device?
This device is registered under product classification code LYC.
Similar Classification Devices (LYC)
Other Devices by UNICARE BIOMEDICAL INC.
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