FDA.reportPublic FDA data

3.5mm Long Cortex Drill

Primary DI
00811954012953
Brand
3.5mm Long Cortex Drill
Company
INTERVENTIONAL SPINE, INC
Model
6038
Catalog number
6038
Published
2015-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811954012953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811954012953008119540129538119540129530811954012953

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpieceA manually-powered, hand-held, surgical device intended to be used to generate a rotary motion to an endpiece during a surgical procedure for e.g., cutting, sculpting, trepanning, drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon holding the top of the brace steady whilst rotating it with horizontal crankshaft-like movements with the other hand; or 2) a drill powered by the rotation of a side-mounted, handle; it may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(800) 497-0484cs@i-spineinc.com

Regulatory Flags#

DUNS number
017663522
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
000119540134488 Degree Lordotic, Opticage Expandable Interbody Implant9101-219101-212016-05-25
81195401082986Opticage Expandable Interbody Implant9080-009080-002015-09-14
81195401107962Opticage Expandable Interbody Implant9080-019080-012015-09-14
81195401108648Opticage Expandable Interbody Implant9080-029080-022015-09-14
81195401109393Opticage Expandable Interbody Implant9080-039080-032015-09-14
81195401110900Opticage Expandable Interbody Implant9080-049080-042015-09-14
81195401111686Opticage Expandable Interbody Implant9080-059080-052015-09-14
81195401112362Opticage Expandable Interbody Implant9080-069080-062015-09-14
81195401113048Opticage Expandable Interbody Implant9080-079080-072015-09-14
81195401114724Opticage Expandable Interbody Implant9080-089080-082015-09-14
81195401115400Opticage Expandable Interbody Implant9080-099080-092015-09-14
81195401116186Opticage Expandable Interbody Implant9080-109080-102015-09-14
81195401117862Opticage Expandable Interbody Implant9080-119080-112015-09-14
81195401245886Opticage Expandable Interbody Implant9080-129080-122015-09-23
81195401246562Opticage Expandable Interbody Implant9080-139080-132015-09-23
81195401247248Opticage Expandable Interbody Implant9080-149080-142015-09-23
81195401248924Opticage Expandable Interbody Implant9080-159080-152015-09-23
81195401249600Opticage Expandable Interbody Implant9080-169080-162015-09-23
81195401250286Opticage Expandable Interbody Implant9080-179080-172015-09-23
81195401251962Opticage Expandable Interbody Implant9080-189080-182015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
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08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
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08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24