FDA.reportPublic FDA data

DARCO

Primary DI
00889797057998
Brand
DARCO
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
77707514
Catalog number
77707514
Device description
Headed Drill Bit
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797057998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797057998008897970579988897970579980889797057998

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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