FDA.reportPublic FDA data

FRT-4.3/5.0

Primary DI
08800021124202
Brand
FRT-4.3/5.0
Company
MCT Bio
Model
FRT-4.3/5.0
Catalog number
FRT-4.3/5.0
Device description
Fixture Remover Trephine Bur 4.3/5.0
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800021124202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021124202088000211242028800021124202

GMDN Terms#

Term, Definition table
TermDefinition
Manual cranial rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313337373mct@mctbio.com

Regulatory Flags#

DUNS number
694484789
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800021124066SRA-01SRA-01SRA-012024-07-18
08800021124127SRG-IOSRG-IOSRG-IO2024-07-18
08800021124134SRG-SHSRG-SHSRG-SH2024-07-18
08800021124141SRG-HSRG-HSRG-H2024-07-18
08800021124301SRG-3INSRG-3INSRG-3IN2024-07-18
08800021124325SRG-NANSRG-NANSRG-NAN2024-07-18
08800021124332SRG-NANSRG-NANSRG-NAN2024-07-18
08800021124356SRG-NTRSRG-NTRSRG-NTR2024-07-18
08800021124363SRG-NTWSRG-NTWSRG-NTW2024-07-18
08800021124424SRG-BLRPSRG-BLRPSRG-BLRP2024-07-18
08800021124431SRG-BLNPSRG-BLNPSRG-BLNP2024-07-18
08800021124479SRD-02SRD-02SRD-022024-07-18
08800021125483PLD-1.8PLD-1.8PLD-1.82024-07-18
08800021123144Adapter-1Adapter-1Adapter-12024-07-17
08800021123168Adapter-AAdapter-AAdapter-A2024-07-17
08800021123175Adapter-HAdapter-HAdapter-H2024-07-17
08800021123243BEC-2.6BEC-2.6BEC-2.62024-07-17
08800021123267BEC-3.4BEC-3.4BEC-3.42024-07-17
08800021123274BEC-3.8BEC-3.8BEC-3.82024-07-17
08800021123281BEC-4.3BEC-4.3BEC-4.32024-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08