FDA.reportPublic FDA data

MULTILOC

Primary DI
07611819425545
Brand
MULTILOC
Company
Synthes GmbH
Model
03.019.004S
Catalog number
03019004S
Device description
11.5MM HOLLOW DRILL BIT FOR 9.5MM MULTILOC PROX NAIL-STER
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
07611819425545Direct MarkingGS10
10886982069405PrimaryGS10
10886982069412PrimaryGS10
H679030190040SecondaryHIBCC0
H67903019004S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819425545076118194255457611819425545
1088698206940510886982069405
1088698206941210886982069412

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

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Primary DI, Brand, Company table
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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