FDA.reportPublic FDA data

BRM TOOL Titanium Screw

Primary DI
08057717550054
Brand
BRM TOOL Titanium Screw
Company
BRM EXTREMITIES SRL
Model
2.6x20 mm - Sterile
Catalog number
STO126020PS
Published
2023-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057717550054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717550054080577175500548057717550054

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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.

Contacts#

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

Regulatory Flags#

DUNS number
435126746
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057717550535BRM TOOL Titanium ScrewTOOL Ø 2.6 x 10STO126010PS2026-09-30
08057717550542BRM TOOL Titanium ScrewTOOL Ø 2.6 x 11 SHORT THREADSTO126011PS2026-09-30
08057717550566BRM TOOL Titanium ScrewTOOL Ø 2.6 x 13 SHORT THREADSTO126013PS2026-09-30
08057717550580BRM TOOL Titanium ScrewTOOL Ø 2.6 x 15 SHORT THREADSTO126015PS2026-09-30
08057717550597BRM TOOL Titanium ScrewTOOL Ø 2.6 x 17 SHORT THREADSTO126017PS2026-09-30
08057717550610BRM TOOL Titanium ScrewTOOL Ø 2.6 x 21 SHORT THREADSTO126021PS2026-09-30
08057717550627BRM TOOL Titanium ScrewTOOL Ø 2.6 x 23 SHORT THREADSTO126023PS2026-09-30
08057717550641BRM TOOL Titanium ScrewTOOL Ø 2.6 x 25 SHORT THREADSTO126025PS2026-09-30
08057717550665BRM TOOL Titanium ScrewTOOL Ø 2.6 x 27 SHORT THREADSTO126027PS2026-09-30
08057717550689BRM TOOL Titanium ScrewTOOL Ø 2.6 x 29 SHORT THREADSTO126029PS2026-09-30
08057717550702BRM TOOL Titanium ScrewTOOL Ø 2.6 x 31 SHORT THREADSTO126031PS2026-09-30
08057717550726BRM TOOL Titanium ScrewTOOL Ø 2.6 x 33 SHORT THREADSTO126033PS2026-09-30
08057717550740BRM TOOL Titanium ScrewTOOL Ø 2.6 x 35 SHORT THREADSTO126035PS2026-09-30
08057717550764BRM TOOL Titanium ScrewTOOL Ø 2.6 x 37 SHORT THREADSTO126037PS2026-09-30
08057717550788BRM TOOL Titanium ScrewTOOL Ø 2.6 x 39 SHORT THREADSTO126039PS2026-09-30
08057717550009BRM TOOL Titanium ScrewTOOL Ø 2.2 x 20STO122020PS2025-07-09
08057717550016BRM TOOL Titanium ScrewTOOL Ø 2.2 x 18STO122018PS2025-07-09
08057717550023BRM TOOL Titanium ScrewTOOL Ø 2.2 x 22STO122022PS2025-07-09
08057717550030BRM TOOL Titanium ScrewTOOL Ø 2.6 x 16STO126016PS2025-07-09
08057717550047BRM TOOL Titanium ScrewTOOL Ø 2.6 x 18STO126018PS2025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550368BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550382BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550405BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550429BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550443BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550467BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550481BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09