FDA.report

Anchor Screw Driver Wrench

Primary DI
08800265645983
Brand
Anchor Screw Driver Wrench
Company
ARUM DENTISTRY Co., Ltd.
Model
GASDW
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
08800265645983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800265645983088002656459838800265645983

GMDN Terms

TermDefinition
Surgical torque wrench adaptorA component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.

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

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