FDA.reportPublic FDA data

BRM TOOL Instruments Kit

Primary DI
08053782781768
Brand
BRM TOOL Instruments Kit
Company
BRM EXTREMITIES SRL
Model
Instruments kit for the implant of BRM Extremities
Catalog number
KIT.TOOL-00
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
08053782781768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782781768080537827817688053782781768

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+3903411693087info@brm-extremities.com

Regulatory Flags#

DUNS number
435126746
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053782783724BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.0 mmSTVI224XXLP2026-04-29
08053782783656BRM INSTRUMENTQuick Coupling Silicone HandleUAOI0SA00S2026-03-24
08053782783663BRM INSTRUMENTQuick Coupling Silicone Handle PROUAOI0SA00L2026-03-24
08053782783670BRM INSTRUMENTJ-Type Quick Coupling Silicone HandleUAOI0SJ0002026-03-24
08053782783687BRM INSTRUMENTQuick Coupling Silicone Handle with ratchetUAOI0SAC0S2026-03-24
08053782783694BRM INSTRUMENTQuick Coupling Silicone Handle PRO with ratchetUAOI0SAC0L2026-03-24
08053782783700BRM INSTRUMENTJ-Type Quick Coupling Silicone Handle with ratchetUAOI0SJC002026-03-24
08053782783748TOOL VIP XL Instruments KitInstruments kit for the implant of BRM ExtremitiesKIT.TOOLVIP-012026-03-24
08053782783731BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.9mmSTVI234XXLP2026-02-19
08053782781720BRM TOOL PRO Instruments KitInstruments KitKIT.TOOLPRO-002025-07-15
08053782780082BRM TOOL PRO SCREWS INSTRUMENTLong cannulated Screwdriver BTX20STAI100020L2025-10-15
08053782780099BRM TOOL PRO SCREWS INSTRUMENTLong solid Screwdriver BTX20STAI100020PL2025-10-15
08053782780105BRM TOOL SCREWS INSTRUMENTLong cannulated Screwdriver BTX25STOI100025L2025-10-15
08053782780112BRM TOOL SCREWS INSTRUMENTLong solid Screwdriver BTX25STOI100025PL2025-10-15
08053782780372BRM INSTRUMENTJ-Type Quick Coupling HandleUAOI0MJ1002025-10-15
08053782780389BRM TOOL PRO SCREWS INSTRUMENTMetallic sterilization tray for instruments – TOOLSTOI056070BPL2025-10-15
08053782780396BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 1.6STAIGW0162025-10-15
08053782780402BRM TOOL PRO SCREWS INSTRUMENTGuidedrill Ø 3.9STAIGD0392025-10-15
08053782780419BRM TOOL PRO SCREWS INSTRUMENTTissue protection Sleeve Ø 5.6STAIPS0562025-10-15
08053782780426BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 2.5STAIGW0252025-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31