FDA.report

SA-004

Primary DI
08800046045865
Brand
SA-004
Company
GNI Co.,Ltd
Model
SA-004
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

Related Records

Product Codes

CodeName
ECTDriver, Band, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECTDriver, Band, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800046045865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800046045865088000460458658800046045865

GMDN Terms

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
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

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 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
08800046045810SA-002GNI Co.,LtdECT2023-10-11
08800046045827SA-003GNI Co.,LtdECT2023-10-11
08800046045834SA-005GNI Co.,LtdECT2023-10-11
08800046045858SA-006GNI Co.,LtdECT2023-10-11
08800046045872SA-020GNI Co.,LtdECT2023-10-11
08800046045889SA-010GNI Co.,LtdECT2023-10-11
08800046046695SA-100GNI Co.,LtdECT2023-10-11
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
08809162705530Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705547Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14