FDA.reportPublic FDA data

BURRS

Primary DI
08053782784752
Brand
BURRS
Company
BRM EXTREMITIES SRL
Model
CR 2020 60 S
Catalog number
M3B06S6S
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
HTTBurr, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053782784752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782784752080537827847528053782784752

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

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
+39 03411693087info@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
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
07899258658230Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658247Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658254Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658261Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658278Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658285Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258638867Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638874Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638881Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638898Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638911Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638928Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
08809288930007IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930014IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930021IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930038IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930045IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930052IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930069IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930076IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930083IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930090IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930106IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930113IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930120IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930137IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930144IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930151IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930168IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930175IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13