FDA.reportPublic FDA data

BRM BIOPLAN INSTRUMENT

Primary DI
08057717553727
Brand
BRM BIOPLAN INSTRUMENT
Company
BRM EXTREMITIES SRL
Model
Probe – Bioplan
Catalog number
SBPI10S001
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
08057717553727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717553727080577175537278057717553727

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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
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
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
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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03