FDA.reportPublic FDA data

"1/4"" Square Drill Chuck"

Primary DI
00810131880606
Brand
"1/4"" Square Drill Chuck"
Company
Surgentec, LLC
Model
SR99-6002
Published
2024-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810131880606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131880606008101318806068101318806060810131880606

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill chuckA device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131885045ION Non CervicalSR17-10002026-07-28
00810131881795ION Disposable Instrument KitTI-K-10002026-03-09
00810131881801ION 55 Facet Implant - SterileTI-K-552026-03-09
00810131881818ION 60 Facet Implant - SterileTI-K-602026-03-09
00810131881825ION 65 Facet Implant - SterileTI-K-652026-03-09
00810131882433ION-C Navigation LocatorSR12-25122026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSR12-65102026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSR12-65112026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSR12-65092026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSR21-63052026-07-06
00810131882556TiLink-L Navigation Drill GuideSR21-63012026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSR21-63042026-07-06
00810131882617TiLink-L Navigation Impact CapSR21-63032026-07-06
00810131882761Facet Sterile Implant - 55FI-S-552026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalFIC-10002026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSR12-27002026-07-06
00810131883669Ion Navigation Inserter AOSR12-65012026-07-06
00810131884772ION-C Final KitTI-C-10002026-07-06
00810131884871ION-C Navigation Reusable TraySR25-70052026-07-06
00810131884895ION-C ReusableSR25-10002026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
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00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31