FRT-4.3/5.0 FRT-4.3/5.0

GUDID 08800021124202

Fixture Remover Trephine Bur 4.3/5.0

MCT Bio

Manual cranial rotary handpiece, reusable

• Primary Device ID: 08800021124202
• NIH Device Record Key: 8f3e3f80-a6e3-42dc-b9e5-01f819f24111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRT-4.3/5.0
• Version Model Number: FRT-4.3/5.0
• Catalog Number: FRT-4.3/5.0
• Company DUNS: 694484789
• Company Name: MCT Bio
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com
• Phone: +82313337373
• Email: mct@mctbio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800021124202 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

[08800021124202]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-05

Devices Manufactured by MCT Bio

• 08800021123144 - Adapter-1: 2024-07-25 Adapter 1 Adapter for ratchet
• 08800021123168 - Adapter-A: 2024-07-25 Adapter-A Adapter for handpiece
• 08800021123175 - Adapter-H: 2024-07-25 Adapter-H IMPLANT-RESCUE-ADAPT Adapter for hand BONE-EXPAND-HP-ADAPT
• 08800021123243 - BEC-2.6: 2024-07-25 Bone Expander Tip ø2.6 BONE-EXPAND-2.6-TIP
• 08800021123267 - BEC-3.4: 2024-07-25 Bone Expander Tip ø3.4 BONE-EXPAND-3.4-TIP
• 08800021123274 - BEC-3.8: 2024-07-25 Bone Expander Tip ø3.8 BONE-EXPAND-3.8-TIP
• 08800021123281 - BEC-4.3: 2024-07-25 Bone Expander Tip ø4.3 BONE-EXPAND-4.3-TIP
• 08800021124097 - FRW-01: 2024-07-25 Remover Wrench BONE-EXPANDER-WRENCH