FDA.reportPublic FDA data

GEOFIT

Primary DI
10886705012909
Brand
GEOFIT
Company
DEPUY MITEK, LLC
Model
254322
Catalog number
254322
Device description
GEOFIT Drill Bit 3.2mm
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10886705012909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501290910886705012909

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or 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 who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which 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
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705011049STRAIGHTSHOT2322152322152015-09-01
10886705011056STRAIGHTSHOT2322202322202015-09-01
10886705017836BRISTOW LATARJET2851802851802015-09-01
10886705022533BRISTOW LATARJET2851432851432015-09-01
10886705004980VERSALOK2154402154402015-09-01
10886705018178BRISTOW LATARJET2853452853452015-09-01
10886705025213EXPRESSEW2141592141592017-03-17
10886705007516FASTIN ETHIBOND2221522221522015-09-01
20886705000903NA2103092103092015-09-01
10886705000951NA2104092104092015-09-01
10886705001088LUPINE ETHIBOND2107102107102015-09-01
10886705001958QUICKANCHOR PANACRYL2121312121312015-09-01
10886705001989GII QUICKANCHOR PANACRYL2121342121342015-09-01
10886705001996QUICKANCHOR PANACRYL2121352121352015-09-01
10886705002047ETHIBOND2123102123102015-09-01
20886705002051ETHIBOND2123152123152015-09-01
10886705002061GII ETHIBOND2124502124502015-09-01
10886705002184PANALOK QUICKANCHOR PANACRYL2127322127322015-09-01
10886705002191PANALOK QUICKANCHOR ORTHOCORD2127332127332015-09-01
20886705002204GII PANACRYL2127342127342015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190457NAPACIFIC INSTRUMENTS, INC.HTW2026-05-26
04048844358617MUTARS®implantcast GmbHHTW2026-03-24
04048844358716MUTARS®implantcast GmbHHTW2026-03-24
04048844358792MUTARS®implantcast GmbHHTW2026-03-24
04048844358839MUTARS®implantcast GmbHHTW2026-03-24
00840314270245gSourceGSOURCE LLCHTW2026-03-20
00840314270252gSourceGSOURCE LLCHTW2026-03-20
00840314270269gSourceGSOURCE LLCHTW2026-03-20
00763000884543n/aMEDTRONIC SOFAMOR DANEK, INC.HTW2026-03-13
00888867500891Arthrex®ARTHREX, INC.HTW2026-03-13
00888867500921Arthrex®ARTHREX, INC.HTW2026-03-13
00817438028618N/AOmega Surgical Instruments IncHTW2026-03-03
06974940307007endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307021endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
00889024706484Vanguard®Biomet Orthopedics, LLCHTW2026-02-27
00841435124929TecometTECOMET INC.HTW2026-02-26
08053782783731BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-02-19
00190376709253AMP IIALPHATEC SPINE, INC.HTW2026-02-18
00810112597455TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00810112598896TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00199150062973Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-02-09
00889024683891G7® Revision Acetabular SystemZimmer, Inc.HTW2026-02-05
04026575282883General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575299188TrabecuLink Augments InstrumentsWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575414932General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575427130General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
00810056993122corraCarlsmed, Inc.HTW2026-01-30
00810056993153corraCarlsmed, Inc.HTW2026-01-30
00810056993160corraCarlsmed, Inc.HTW2026-01-30