FDA.report

IBS™

Primary DI
03760225714232
Brand
IBS™
Company
IN2BONES
Model
G01 00131
Published
2020-06-11
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
03760225714232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760225714232037602257142323760225714232

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+33472292626contact@in2bones.com

Regulatory Flags

DUNS number
263616749
Device count
1
DM exempt
false
Premarket exempt
false
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 DIBrandModelCatalogPublished
03701337618896QUANTUM®M05 10211M05 102112025-12-09
03701337618919QUANTUM®M05 10212M05 102122025-12-09
03701337621995QUANTUM®M05 10213M05 102132025-12-09
03701337612085QUANTUMM05 00192M05 001922024-12-27
03701337600532QUANTUMM05 00541M05 005412024-12-13
03701337600549QUANTUMM05 00551M05 005512024-12-13
03701337600556QUANTUMM05 00561M05 005612024-12-13
03701337600563QUANTUMM05 00571M05 005712024-12-13
03701337600570QUANTUMM05 00581M05 005812024-12-13
03701337600587QUANTUMM05 00591M05 005912024-12-13
03701337600594QUANTUMM05 00601M05 006012024-12-13
03701337600600QUANTUMM05 00611M05 006112024-12-13
03701337600617QUANTUMM05 00621M05 006212024-12-13
03701337600624QUANTUMM05 00631M05 006312024-12-13
03701337600631QUANTUMM05 00641M05 006412024-12-13
03701337600648QUANTUMM05 00651M05 006512024-12-13
03701337600679QUANTUMM05 00681M05 006812024-12-13
03701337600686QUANTUMM05 00691M05 006912024-12-13
03701337600815QUANTUMM05 00811M05 008112024-12-13
03701337600822QUANTUMM05 01161M05 011612024-12-13

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