FDA.reportPublic FDA data

Orthopedic Instruments

Primary DI
07899258648729
Brand
Orthopedic Instruments
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
SELF-CENTERING BONE FORCEPS
Catalog number
169-164
Published
2026-06-01
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
07899258648729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258648729078992586487297899258648729

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
07901125602533Expert KnotlessExpert KnotlessFD0010102026-05-28
07899258650500Orthopedic InstrumentsREDUCTION FORCEPS JAW169-1652026-05-19
07899258699943Orthopedic InstrumentsT7 HEXALOBULAR DRIVER TIP 95mm223-308-F2026-05-19
07901125602502Orthopedic InstrumentsFRESA PARA PLACA DORSAL STT180-3802026-05-13
07901125602519Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 12F180-3812026-05-13
07901125602526Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 8F180-3822026-05-13
07899258601847Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x11.0mm223-24-11-BP2026-04-08
07899258601854Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x13.0mm223-24-13-BP2026-04-08
07899258601861Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x15.0mm223-24-15-BP2026-04-08
07899258601878Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x11.0mm223-24-11-C2026-04-08
07899258601885Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x13.0mm223-24-13-C2026-04-08
07899258601892Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x15.0mm223-24-15-C2026-04-08
07899258601908Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x11.0mm223-27-11-BP2026-04-08
07899258601915Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x13.0mm223-27-13-BP2026-04-08
07899258601922Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x15.0mm223-27-15-BP2026-04-08
07899258601939Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x11.0mm223-27-11-C2026-04-08
07899258601946Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x13.0mm223-27-13-C2026-04-08
07899258601953Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x15.0mm223-27-15-C2026-04-08
07899258612546Super Upper Limbs Versalock Plating SystemVERSALOCK TORXDRIVE MINI SCREW T6 Ø2.0x15.0mm308-20-15-B2026-04-08
07899258663500Super Upper Limbs Versalock Plating SystemVERSALOCK RADIUS SHAFT PLATE, VOLAR 160.0mm180-1122026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
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00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
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07630542799051Surgical Manual InstrumentMedacta International SALXH2026-05-29
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07630542799075Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542799082Surgical Manual InstrumentMedacta International SALXH2026-05-29