FDA.report

Screw Driver Hand

Primary DI
08800055792873
Brand
Screw Driver Hand
Company
ARUM DENTISTRY Co., Ltd.
Model
SDH12722
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800055792873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800055792873088000557928738800055792873

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
557821945
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
08800055791203NB Master KitMAK-SET2026-03-24
08800055791210NB Regular Kit REK-SET2026-03-24
08800055792774Fixture Driver MachineFDM25M2026-03-24
08800055792781Fixture Driver MachineFDM31M2026-03-24
08800055792798Fixture Driver MachineFDM26R2026-03-24
08800055792804Fixture Driver MachineFDM32R2026-03-24
08800055792910Torque ExtensionTE012026-03-24
08800055792958Trial PinTP55132026-03-24
08800055792965Trial PinTP60132026-03-24
08800055792972Trial PinTP65132026-03-24
08800055792996Torque RatchetTR012026-03-24
08800265644320SD Surgical KitSDSK-SET2026-03-24
08800265645501Torque RatchetTR032026-03-24
08800265645532SD Multi Driver WrenchGSMD012026-03-24
08800265646492Guide Fixture Driver MachineGFDM31R2026-03-24
08800265646515SD Multi Driver MachineGSMD032026-03-24
08800265646522Anchor Screw Driver MachineGASDM2026-03-24
08800265646560Guide Fixture Driver MachineGFDM31M2026-03-24
08800275822800ARUM Prosthetic KitAPK-SET2026-03-24
08800275825498Torx Remover ToolTRTL2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076409996Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
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08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423718URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423725URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24