FDA.reportPublic FDA data

BRM TOOL SCREW INSTRUMENT

Primary DI
08053782781713
Brand
BRM TOOL SCREW INSTRUMENT
Company
BRM EXTREMITIES SRL
Model
Dispenser for K-wire 150mm
Catalog number
UKWI00150T
Published
2025-04-04
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
08053782781713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782781713080537827817138053782781713

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin containerA non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. 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
08053782783830TITANIUM SCREWØ 2.2 x 12M3ST22012PS2026-10-19
08053782783847TITANIUM SCREWØ 2.2 x 14M3ST22014PS2026-10-19
08053782783915TITANIUM SCREWØ 2.2 x 28M3ST22028PS2026-10-19
08053782783922TITANIUM SCREWØ 2.2 x 30M3ST22030PS2026-10-19
08053782783939TITANIUM SCREWØ 2.2 x 32M3ST22032PS2026-10-19
08053782783946TITANIUM SCREWØ 2.2 x 34M3ST22034PS2026-10-19
08053782783953TITANIUM SCREWØ 2.2 x 36M3ST22036PS2026-10-19
08053782783960TITANIUM SCREWØ 2.2 x 38M3ST22038PS2026-10-19
08053782783977TITANIUM SCREWØ 2.2 x 40M3ST22040PS2026-10-19
08053782784134TITANIUM SCREWØ 4.0 x 40M3SO40040PS2026-10-19
08053782784141TITANIUM SCREWØ 4.0 x 42M3SO40042PS2026-10-19
08053782784158TITANIUM SCREWØ 4.0 x 44M3SO40044PS2026-10-19
08053782784165TITANIUM SCREWØ 4.0 x 46M3SO40046PS2026-10-19
08053782784172TITANIUM SCREWØ 4.0 x 48M3SO40048PS2026-10-19
08053782784189TITANIUM SCREWØ 4.0 x 50M3SO40050PS2026-10-19
08053782784264CHAMFERED SCREWØ 2.5 x 20M3SS25020S2026-10-19
08053782784271CHAMFERED SCREWØ 2.5 x 22M3SS25022S2026-10-19
08053782784288CHAMFERED SCREWØ 2.5 x 24M3SS25024S2026-10-19
08053782784295CHAMFERED SCREWØ 2.5 x 26M3SS25026S2026-10-19
08053782784301CHAMFERED SCREWØ 2.5 x 28M3SS25028S2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396389TruTORQ Offset T-Handle Sterile, Single UseEca Medical InstrumentsLXH2026-10-20
10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16