FDA.reportPublic FDA data

BRM TOOL SCREWS INSTRUMENT

Primary DI
08057717553314
Brand
BRM TOOL SCREWS INSTRUMENT
Company
BRM EXTREMITIES SRL
Model
Depth Gauge 110 mm
Catalog number
STAI270000M
Published
2025-10-15
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
08057717553314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717553314080577175533148057717553314

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
08053782781652Bioplan Instruments KitInstruments kit for the implant of BRM ExtremitiesKIT.BIOPLAN2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTScrewdriver – BioplanSBPI1CI0012026-08-18
08057717553642BRM BIOPLAN INSTRUMENTExtractor Screwdriver - BioplanSBPI1CE0022026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBioplan - Trial Size 7SBPI10P0072026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBioplan - Trial Size 8SBPI10P0082026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBioplan - Trial Size 9SBPI10P0092026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBioplan - Trial Size 10SBPI10P0102026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBioplan - Trial Size 11SBPI10P0112026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBioplan - Trial Size 12SBPI10P0122026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBioplan - Trial Size 13SBPI10P0132026-08-18
08057717553727BRM BIOPLAN INSTRUMENTProbe – BioplanSBPI10S0012026-08-18
08057717553734BRM BIOPLAN INSTRUMENTGuide wire Ø 2 mm - BioplanSBPI1PG0012026-08-18
08057717553741BRM BIOPLAN INSTRUMENTPush wireSBPI1SF0012026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBioplan Sterilization TraySBPI000000B2026-08-18
08053782783755Bioplan Titanium implantBioplan Titanium implant 7DBI1070132026-08-14
08053782783762Bioplan Titanium implantBioplan Titanium implant 8DBI1080142026-08-14
08053782783779Bioplan Titanium implantBioplan Titanium implant 9DBI1090152026-08-14
08053782783786Bioplan Titanium implantBioplan Titanium implant 10DBI1100162026-08-14
08053782783793Bioplan Titanium implantBioplan Titanium implant 11DBI1110172026-08-14
08053782783809Bioplan Titanium implantBioplan Titanium implant 12DBI1120182026-08-14

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