FDA.reportPublic FDA data

BRM INSTRUMENT

Primary DI
08053782781744
Brand
BRM INSTRUMENT
Company
BRM EXTREMITIES SRL
Model
Quick Coupling Handle PRO
Catalog number
UAOI0MA001
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
08053782781744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782781744080537827817448053782781744

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep at room temperature and away from direct sources of light

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
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

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Primary DI, Brand, Company table
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00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
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