SA-002

Primary DI
08800046045810
Brand
SA-002
Company
GNI Co.,Ltd
Model
SA-002
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ECTDriver, Band, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECTDriver, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046045810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046045810088000460458108800046045810

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA 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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800046051484SS650SS6502025-04-04
08800046051309SSBC-M22-464GSSBC-M22-464G2024-06-18
08800046051316SSBC-M22-364GSSBC-M22-364G2024-06-18
08800046051323SSBC-M22-264GSSBC-M22-264G2024-06-18
08800046051330SSBC-M22-164GSSBC-M22-164G2024-06-18
08800046051385SSBC-M22-1M44GSSBC-M22-1M44G2024-06-18
08800046027540IES1-1001IES1-10012024-06-04
08800046045896P01-01P01-012024-06-04
08800046046602SN02-1018SN02-10182024-06-04
08800046050357ELT-01ELT-012024-06-04
08800046000642SA1208CSA1208C2022-12-13
08800046000659SA1210CSA1210C2022-12-13
08800046000666SA1406CSA1406C2022-12-13
08800046000673SA1408CSA1408C2022-12-13
08800046000680SA1410CSA1410C2022-12-13
08800046000697SA1606CSA1606C2022-12-13
08800046000703SA1608CSA1608C2022-12-13
08800046000710SA1610CSA1610C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806145440129Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440136Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440143Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440150Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440167Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440174Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145484086Orthodontic DriverDENTOS Inc.ECT2025-05-02
00371347018325Advance Dental ProductsThe Atlanta Dental Supply CompanyECT2025-01-02
08800041038121MalletSurgident Co.,Ltd.ECT2023-10-18
08800041039128Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041039135Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800041039807Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041053469Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800046045797SA-001GNI Co.,LtdECT2023-10-11
08800046045827SA-003GNI Co.,LtdECT2023-10-11
08800046045834SA-005GNI Co.,LtdECT2023-10-11
08800046045858SA-006GNI Co.,LtdECT2023-10-11
08800046045865SA-004GNI Co.,LtdECT2023-10-11
08800046045872SA-020GNI Co.,LtdECT2023-10-11
08800046045889SA-010GNI Co.,LtdECT2023-10-11
08800046046695SA-100GNI Co.,LtdECT2023-10-11
08800041052455Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08800041052462Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08809162706391Simple LineDentium Co., Ltd.ECT2020-05-14
08809162705141Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705158Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705165Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705189Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705516Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705523Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14