FDA.reportPublic FDA data

Orthopedic Instruments

Primary DI
07899258633350
Brand
Orthopedic Instruments
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
GUIDE DRILL DOUBLE 2,7mm
Catalog number
106-85
Published
2026-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258633350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258633350078992586333507899258633350

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900865213
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
07899258616506Orthopedic InstrumentsSYNDESMOSIS CLAMP314-1002026-07-07
07899258625348Orthopedic InstrumentsGUIDE WIRE Ø1.0x190.0mm WITHOUT THREAD106-812026-07-07
07899258625355Orthopedic Instruments1,0x190mm THREADED GUIDE WIRE106-822026-07-07
07899258633367Orthopedic Instruments4.0mm CANCELLOUS TAP106-862026-07-07
07899258633374Orthopedic InstrumentsSMALL DEPTH GAUGE106-872026-07-07
07899258633381Orthopedic InstrumentsØ1.0x250.0mm WIRE106-882026-07-07
07899258634388Orthopedic InstrumentsSCREW EXTRACTOR 3.5mm169-4252026-07-07
07899258636290Orthopedic InstrumentsØ3.2mm WIRE CUTTING FORCEPS172-19A2026-07-07
07899258645094Orthopedic InstrumentsSCREW DRIVER TIP HEXALOBULAR T15 FIT AO307-1102026-07-07
07899258646527Orthopedic Instruments1.0x20.0x100.0mm GUIDE WIRE WITH SPHERICAL STOP223-3062026-07-07
07899258655864Orthopedic InstrumentsINSTRUMENTAL TRAY FOR ANKLE FRACTURE314-70022026-07-07
07899258655871Orthopedic InstrumentsIMPLANT TRAY TO ANKLE FRACTURE314-70042026-07-07
07899258655932Orthopedic InstrumentsVERSALOCK SYSTEM KIT FOR ANKLE314-70012026-07-07
07899258655949Orthopedic InstrumentsANKLE FRACTURE IMPLANT TRAY314-70032026-07-07
07899258656151Orthopedic InstrumentsIDENTIFICATION AND ORIENTATION PANEL314-70082026-07-07
07899258695464Orthopedic InstrumentsVERSA AND VERSALOCK SCREW CASES Ø2.7mm AND Ø3.5mm314-70052026-07-07
07899258695471Orthopedic InstrumentsMINI CANNULATED SCREW CASE Ø4.0mm AND DEDICATED IN314-70062026-07-07
07899258695488Orthopedic InstrumentsVERSALOCK MINI PLATE CASE314-70072026-07-07
07901125601130GMReis Suture AnchorsFASTLOCK - KNOTLESS PEEK ANCHOR Ø4.75x15.0/19.1mm 320-475191-PE3H2026-06-25
07899258602042Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø1.8mm180-3902026-06-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09