MCBio Supertack Tack 3mm - N.5

GUDID 08056992093010

The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

MC BIO SRL

Craniofacial bone tack, non-bioabsorbable
Primary Device ID08056992093010
NIH Device Record Key29fcfb75-289c-4484-bf59-b489de7ba826
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCBio Supertack Tack 3mm - N.5
Version Model Number9514010-5
Company DUNS338319497
Company NameMC BIO SRL
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056992093010 [Primary]
GS108057639710949 [Unit of Use]

FDA Product Code

DZLScrew, Fixation, Intraosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


[08056992093010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-25
Device Publish Date2024-12-17

Devices Manufactured by MC BIO SRL

08057639710567 - Specialist Organizer2025-07-01 Specialist Organizer for MCBio tacks
08057639710574 - Tip with Indexable Stop2025-07-01 Tip with Indexable Stop for MCBio Tacks
08057639710598 - Offset Tip SP2025-07-01 Offset Tip Specialist for MCbio Tacks
08057639710604 - Long Tip SP2025-07-01 Long Tip Specialist for MCBio tacks
08057639710628 - GBR MODULAR SET2025-07-01 GBR MODULAR SET of MCBio
08057639710635 - 5 Scraper box2025-07-01 5 Scraper box
08057639711960 - G-Special box2025-07-01 G-Special box
08057639711977 - Modular Box2025-07-01 Modular Box of MCBio

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