FDA.reportPublic FDA data

Disposable Screwdriver Blade

Primary DI
06903195298587
Brand
Disposable Screwdriver Blade
Company
Kontour(Xi'An) Medical Technology Co.,Ltd.
Model
BPLD60×φ2.8
Catalog number
HKTGJ0107010002
Published
2024-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXLScrewdriver, Skullplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06903195298587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06903195298587069031952985876903195298587

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529652129
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903195108008PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L9H2CF260200102022-12-08
06903195108015PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L10H2CF260200112022-12-08
06903195108039PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L12H2CF260200132022-12-08
06903195108046PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L13H2CF260200142022-12-08
06903195108053PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L14H2CF260200152022-12-08
06903195108060PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L15H2CF260200162022-12-08
06903195108077PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L16H2CF260200172022-12-08
06903195108084PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L17H2CF260200182022-12-08
06903195108091PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L1H1CF260300012022-12-08
06903195108107PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L2H1CF260300022022-12-08
06903195108114PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L3H1CF260300032022-12-08
06903195108121PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L4H1CF260300042022-12-08
06903195108138PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L5H1CF260300052022-12-08
06903195108145PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L6H1CF260300062022-12-08
06903195108152PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L7H1CF260300072022-12-08
06903195108169PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L18H1CF260300082022-12-08
06903195108176PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L8H2CF260300092022-12-08
06903195108183PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L9H2CF260300102022-12-08
06903195108190PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L10H2CF260300112022-12-08
06903195108206PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L11H2CF260300122022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07610733850372OPERACEPB SWISS TOOLS AGGXL2024-09-24
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07610733850563OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850617OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
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00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29
00856482008207Pro-Dex Surgical DriverPRO-DEX, INC.GXL2022-03-29