MCBio Supertack Tack 5mm - N.5

GUDID 08056992093041

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 ID: 08056992093041
• NIH Device Record Key: 37d2a4a8-de68-427d-9189-1b503475d7e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCBio Supertack Tack 5mm - N.5
• Version Model Number: 9514020-5
• Company DUNS: 338319497
• Company Name: MC BIO SRL
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056992093041 [Primary]
GS1	08057639710963 [Unit of Use]

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

[08056992093041]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-25
• Device Publish Date: 2024-12-17

Devices Manufactured by MC BIO SRL

• 08056992093010 - MCBio Supertack Tack 3mm - N.5: 2024-12-25 The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue rege
• 08056992093027 - MCBio Supertack Tack 3mm - N.10: 2024-12-25 The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue rege
• 08056992093034 - MCBio Supertack Tack 4mm - N.5: 2024-12-25 The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue rege
• 08056992093041 - MCBio Supertack Tack 5mm - N.5: 2024-12-25The 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.
• 08056992093041 - MCBio Supertack Tack 5mm - N.5: 2024-12-25 The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue rege