FDA.reportPublic FDA data

SRG-ER

Primary DI
08800021124110
Brand
SRG-ER
Company
MCT Bio
Model
SRG-ER
Catalog number
SRG-ER
Device description
Screw Remover Guide ER(External Regular)IMPLANT-RESCUE-EXT-R
Published
2024-07-17
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
08800021124110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021124110088000211241108800021124110

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053262N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053279N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053286N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01