FDA.report

BADGER

Primary DI
20845854020156
Brand
BADGER
Company
Conmed Corporation
Model
C8584
Catalog number
C8584
Device description
9.5mm x 229mm (9 IN) Badger Cannulated Drill Bit
Published
2021-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854020153Direct MarkingGS10
20845854020156PackageGS11In Commercial Distribution
10845854020159PrimaryGS10
00845854020152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585402015330845854020153
2084585402015620845854020156
1084585402015910845854020159
00845854020152008458540201528458540201520845854020152

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
4
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24
20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
20653405034701CONMEDD8550D85502026-03-24

Other Devices Sharing Product Codes

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