FDA.reportPublic FDA data

BRM BIOPLAN INSTRUMENT

Primary DI
08057717553635
Brand
BRM BIOPLAN INSTRUMENT
Company
BRM EXTREMITIES SRL
Model
Screwdriver – Bioplan
Catalog number
SBPI1CI001
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08057717553635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717553635080577175536358057717553635

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
08053782783816Bioplan Titanium implantBioplan Titanium implant 13DBI1130192026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
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08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759547QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18