FDA.report

DART-FIRE

Primary DI
00840420192455
Brand
DART-FIRE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
DSDS0017
Published
2016-09-17
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

Related Records

Contact Domains

Product Codes

CodeName
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840420192455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420192455008404201924558404201924550840420192455

GMDN Terms

TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
true
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 DIBrandModelCatalogPublished
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes

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30653405990714InfinityConmed CorporationGFG2025-12-01
00889797111386Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.GFG2025-08-26
00889797112154Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.GFG2025-08-26
00889797112161Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.GFG2025-08-26
00889797112758Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.GFG2025-08-26
10888277378285MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-07-18
008401944939323P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008401944939563P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321861213P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321861383P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321861453P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321865033P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321865103P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321866403P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321866573P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321866643P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321871423P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
008411321871593P Hip SystemORTHOPEDIATRICS CORP.GFG2025-06-19
00841132195604PediNailORTHOPEDIATRICS CORP.GFG2025-06-05
00841132195611PediNailORTHOPEDIATRICS CORP.GFG2025-06-05
B666MCG307400IntelliSense Drill TechnologyMCGINLEY ORTHOPAEDIC INNOVATIONS, LLCGFG2025-05-30
00840194472364PNP FemurORTHOPEDIATRICS CORP.GFG2025-05-28
00811714036199SuperhawkRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036205SuperhawkRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036212SuperhawkRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036229SuperhawkRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036540ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036557ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
10888277384934MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-04-17
10888277394803MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-04-17