Eu Mdd Eu Md Class 3 On The Market ๐Ÿ‡ฐ๐Ÿ‡ท South Korea

THE Graft Collagen

Purgo Biologics Inc. ยท ๐Ÿ‡ฐ๐Ÿ‡ท South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08800039005067
Basic UDI-DI Code
B-08800039005067
Reference
TCR-02
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market
Manufacturer
Purgo Biologics Inc.

Additional Description

THE Graft Collagen, a form of block and ring composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon, is a material used to fill, augment, and/or reconstruct periodontal, oral, and maxillofacial defects. The bone mineral matrix is similar to physical and chemical aspects of mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects and can be attached in bone defect site. THE Graft Collagen is sterilized using gamma irradiation. As time passes, THE Graft Collagen is partially transformed by the osteoclast and osteoblast.

CND Nomenclature Codes

Code Description
Q010302 DENTAL GRAFT DEVICES

Certificates

Type Number
MDD Annex II Section 4 1434-MDD-171/2021

Available In Countries

๐Ÿ‡ฎ๐Ÿ‡น Italy

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