BRM TOOL Titanium Screw SOS132019PS

GUDID 08057717555394

BRM EXTREMITIES SRL

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID08057717555394
NIH Device Record Key420689b8-f0b4-442b-afa8-af0c4813e410
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRM TOOL Titanium Screw
Version Model Number3.2x19 mm - Short thread - Sterile
Catalog NumberSOS132019PS
Company DUNS435126746
Company NameBRM EXTREMITIES SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com
Phone+3903411693087
Emailinfo@brm-extremities.com

Device Dimensions

Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter
Length19 Millimeter
Outer Diameter3.2 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, keep dry and away from humidity and direct sources of light and heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS108057717555394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-27
Device Publish Date2023-04-19

On-Brand Devices [BRM TOOL Titanium Screw]

080577175554003.2x21 mm - Short thread - Sterile
080577175553943.2x19 mm - Short thread - Sterile
080577175541063.2x20 mm - Sterile
080577175506032.6x19 mm - Short Thread - Sterile
080577175500542.6x20 mm - Sterile
08057717550276TOOL Ø 2.2 x 12
08057717550252TOOL Ø 2.2 x 10
08057717554502TOOL Ø 3.2 x 60
08057717554496TOOL Ø 4.0 x 58
08057717554489TOOL Ø 3.2 x 58
08057717554472TOOL Ø 4.0 x 56
08057717554465TOOL Ø 3.2 x 56
08057717554458TOOL Ø 4.0 x 54
08057717554441TOOL Ø 3.2 x 54
08057717554434TOOL Ø 4.0 x 52
08057717554427TOOL Ø 3.2 x 52
08057717554410TOOL Ø 4.0 x 50
08057717554403TOOL Ø 3.2 x 50
08057717554397TOOL Ø 4.0 x 48
08057717554380TOOL Ø 3.2 x 48
08057717554373TOOL Ø 4.0 x 46
08057717554366TOOL Ø 3.2 x 46
08057717554359TOOL Ø 4.0 x 44
08057717554342TOOL Ø 3.2 x 44
08057717554335TOOL Ø 4.0 x 42
08057717554328TOOL Ø 3.2 x 42
08057717554311TOOL Ø 4.0 x 40
08057717554304TOOL Ø 3.2 x 40
08057717554298TOOL Ø 4.0 x 38
08057717554281TOOL Ø 3.2 x 38
08057717554274TOOL Ø 4.0 x 36
08057717554267TOOL Ø 3.2 x 36
08057717554250TOOL Ø 4.0 x 34
08057717554243TOOL Ø 3.2 x 34
08057717554236TOOL Ø 4.0 x 32
08057717554229TOOL Ø 3.2 x 32
08057717554212TOOL Ø 4.0 x 30
08057717554205TOOL Ø 3.2 x 30
08057717554199TOOL Ø 4.0 x 28
08057717554182TOOL Ø 3.2 x 28
08057717554175TOOL Ø 4.0 x 26
08057717554168TOOL Ø 3.2 x 26
08057717554151TOOL Ø 4.0 x 24
08057717554144TOOL Ø 3.2 x 24
08057717554137TOOL Ø 4.0 x 22
08057717554120TOOL Ø 3.2 x 22
08057717554113TOOL Ø 4.0 x 20
08057717554090TOOL Ø 4.0 x 18
08057717554083TOOL Ø 3.2 x 18
08057717554076TOOL Ø 4.0 x 16
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.