FDA.reportPublic FDA data

BRM VR Breaking screw instruments

Primary DI
08053782780310
Brand
BRM VR Breaking screw instruments
Company
BRM EXTREMITIES SRL
Model
INSTRUMENTS SET VR
Catalog number
SET.VR
Published
2023-04-19
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
08053782780310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782780310080537827803108053782780310

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, keep dry and away from humidity and direct sources of light and heat.

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
No natural rubber latex
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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