FDA.reportPublic FDA data

Screw Driver

Primary DI
06932195327683
Brand
Screw Driver
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-BALL
Published
2025-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932195327683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195327683069321953276836932195327683

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
554494754
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932195392322BIORES Dental Implant SystemBSM-ZTG37082026-02-28
06932195392339BIORES Dental Implant SystemBSM-ZTG37102026-02-28
06932195392346BIORES Dental Implant SystemBSM-ZTG37122026-02-28
06932195392353BIORES Dental Implant SystemBSM-ZTG37142026-02-28
06932195392360BIORES Dental Implant SystemBSM-ZTG41082026-02-28
06932195392377BIORES Dental Implant SystemBSM-ZTG41102026-02-28
06932195392384BIORES Dental Implant SystemBSM-ZTG41122026-02-28
06932195392391BIORES Dental Implant SystemBSM-ZTG41142026-02-28
06932195392407BIORES Dental Implant SystemBSM-ZTG43082026-02-28
06932195392414BIORES Dental Implant SystemBSM-ZTG43102026-02-28
06932195392421BIORES Dental Implant SystemBSM-ZTG43122026-02-28
06932195392438BIORES Dental Implant SystemBSM-ZTG43142026-02-28
06932195392445BIORES Dental Implant SystemBSM-ZTG48082026-02-28
06932195392452BIORES Dental Implant SystemBSM-ZTG48102026-02-28
06932195392469BIORES Dental Implant SystemBSM-ZTG48122026-02-28
06932195392476BIORES Dental Implant SystemBSM-ZTG48142026-02-28
06932195392483BIORES Dental Implant SystemBSM-ZTG55082026-02-28
06932195392490BIORES Dental Implant SystemBSM-ZTG55102026-02-28
06932195392506BIORES Dental Implant SystemBSM-ZTG55122026-02-28
06932195392513BIORES Dental Implant SystemBSM-ZTG60082026-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
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00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
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08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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