FDA.reportPublic FDA data

Drill Bit Driver

Primary DI
00854515008538
Brand
Drill Bit Driver
Company
Unique Surgical
Model
Ball Joint, Bayonet Connector
Published
2023-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854515008538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854515008538008545150085388545150085380854515008538

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
818-813-8527info@UniqueSurgical.com

Regulatory Flags#

DUNS number
079820535
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080482063Drill BitBayonet Drill Bit Ø3.2 L152026-01-30
00850080482070Drill BitBayonet Drill Bit Ø3.2 L202026-01-30
00850080482087Drill BitBayonet Drill Bit Ø3.2 L252026-01-30
00850080482094Drill BitBayonet Drill Bit Ø3.2 L302026-01-30
00850080482100Drill BitBayonet Drill Bit Ø3.2 L352026-01-30
00850080482117Drill BitBayonet Drill Bit Ø3.2 L402026-01-30
00850080482124Drill BitBayonet Drill Bit Ø3.2 L452026-01-30
00850080482131Drill BitBayonet Drill Bit Ø3.2 L502026-01-30
00850080482148Drill BitBayonet Drill Bit Ø3.2 L552026-01-30
00850080482155Drill BitBayonet Drill Bit Ø3.2 L602026-01-30
00850080482162Drill BitBayonet Drill Bit Ø3.2 L652026-01-30
00850080482179Drill BitBayonet Drill Bit Ø3.2 L702026-01-30
00850080482186Drill BitBayonet Drill Bit Ø3.2 L752026-01-30
00850080482193Drill BitBayonet Drill Bit Ø3.2 L802026-01-30
00854515008002ImpactorFemoral2023-01-06
00854515008989Medacta Glenosphere Impactor TipCannulated2025-09-16
00854515008927ScrewdriverU-Joint, 3.5mm Hex, Hudson Connector2025-08-07
00854515008934ScrewdriverSolid Shaft, 3.5mm Hex, Hudson Connector2025-08-07
00850080482025Screw ForcepsMedacta, with Cap2025-12-18
00850080482032Bone PinMedacta, Fluted2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900039EARP FINAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900152EARP CRADLE ASSEMBLYRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900299EARP, TRIAL 22X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15