Home GUDID 08800046046695 SA-100
Primary DI 08800046046695
Brand SA-100
Company GNI Co.,Ltd
Model SA-100
Published 2023-10-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ECT Driver, Band, Orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ECT Driver, Band, Orthodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800046046695 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800046046695 08800046046695 8800046046695
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 694828541 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08806145440129 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145440136 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145440143 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145440150 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145440167 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145440174 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 08806145484086 Orthodontic Driver DENTOS Inc. ECT 2025-05-02 00371347018325 Advance Dental Products The Atlanta Dental Supply Company ECT 2025-01-02 08800041038121 Mallet Surgident Co.,Ltd. ECT 2023-10-18 08800041039128 Tac Remover Driver Surgident Co.,Ltd. ECT 2023-10-18 08800041039135 Tac Applicator Surgident Co.,Ltd. ECT 2023-10-18 08800041039807 Tac Remover Driver Surgident Co.,Ltd. ECT 2023-10-18 08800041053469 Tac Applicator Surgident Co.,Ltd. ECT 2023-10-18 08800046045797 SA-001 GNI Co.,Ltd ECT 2023-10-11 08800046045810 SA-002 GNI Co.,Ltd ECT 2023-10-11 08800046045827 SA-003 GNI Co.,Ltd ECT 2023-10-11 08800046045834 SA-005 GNI Co.,Ltd ECT 2023-10-11 08800046045858 SA-006 GNI Co.,Ltd ECT 2023-10-11 08800046045865 SA-004 GNI Co.,Ltd ECT 2023-10-11 08800046045872 SA-020 GNI Co.,Ltd ECT 2023-10-11 08800046045889 SA-010 GNI Co.,Ltd ECT 2023-10-11 08809162706391 Simple Line Dentium Co., Ltd. ECT 2020-05-14 08809162705141 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705158 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705165 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705189 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705516 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705523 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705530 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14 08809162705547 Implantium, Superline Dentium Co., Ltd. ECT 2020-05-14