FDA.reportPublic FDA data

CHAMFERED SCREW

Primary DI
08053782784530
Brand
CHAMFERED SCREW
Company
BRM EXTREMITIES SRL
Model
Ø 4.0 x 48
Catalog number
M3SS40048S
Published
2026-10-19
Public version status
New
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
08053782784530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782784530080537827845308053782784530

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep 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
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
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
00842188121678CannCompScrew 1.7mm (SelfDrill)Trimed, INC.HWC2021-01-11