FDA.reportPublic FDA data

OURY-GUYE & FILS

Primary DI
03665624018960
Brand
OURY-GUYE & FILS
Company
ETABLISSEMENTS OURY GUYE ET FILS
Model
A
Catalog number
D11443M
Device description
PAIR OF CORONAL ROD BENDERS
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
03665624018960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665624018960036656240189603665624018960

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
281906511
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665624028471OURY-GUYE & FILSAD11462M2026-01-27
03665624028600OURY-GUYE & FILSAD11252M2026-01-27
03665624028617OURY-GUYE & FILSAD11253M2026-01-27
03665624018991OURY-GUYE & FILSAD11439M2025-12-15
03665624019004OURY-GUYE & FILSAD11438M2025-12-15
03665624020017OURY-GUYE & FILSAD11271M2025-12-15
03665624027788OURY-GUYE & FILSAD11461M2025-12-15
03665624019851OURY-GUYE & FILSAD11288M2022-10-19
03665624028273OURY-GUYE & FILSAL11913M2022-04-06
03665624014566OURY-GUYE ET FILSAL11839M2024-11-22
03665624019219OURY-GUYE & FILSAD11412M2023-03-02
03665624000019OURY-GUYE & FILSAZZ5047302022-04-06
03665624002235OURY-GUYE & FILSAZL1798M2022-04-06
03665624004390OURY-GUYE & FILSAZD1437M2022-04-06
03665624005076OURY-GUYE & FILSAZD1340M2022-04-06
03665624012760OURY-GUYE & FILSAR12339M2022-04-06
03665624018526OURY-GUYE & FILSAD11532M2022-04-06
03665624018977OURY-GUYE & FILSAD11441M2022-04-06
03665624019103OURY-GUYE & FILSAD11427M2022-04-06
03665624019806OURY-GUYE & FILSAD11293M2022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03