FDA.reportPublic FDA data

BONE CEMENT CUP SPLITTER

Primary DI
00810012483117
Brand
BONE CEMENT CUP SPLITTER
Company
BIOPRO, INC.
Model
95-7187
Published
2019-06-10
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

Product Codes#

Code, Name table
CodeName
LODBone Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810012483117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012483117008100124831178100124831170810012483117

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement mixing bowlA sterile device designed for the specific purpose of containing the components that comprise orthopaedic bone cement while these are being mixed prior to application on a patient. It is typically used together with an orthopaedic cement mixer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20923217MTP Targeting Guide Assembly232172025-11-28
M20923227Modular Thumb Rasp Serrated 7.5MM232272025-11-28
M20923228Modular Thumb Rasp Serrated 8.5MM232282025-11-28
M20923229Modular Thumb Rasp Serrated 10.0MM232292025-11-28
M20923230Modular Thumb Rasp Serrated 11.5MM232302025-11-28
M209177990THUMB MOD HEAD TITANIUM 13MM+2177992024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MM177802024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2178012024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MM178062024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2178072024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MM178082024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2178092024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MM177982024-05-30
M209230790MTP FUSION PLATE 5 DEGREE, LEFT230792024-03-26
M209230800MTP FUSION PLATE 5 DEGREE, RIGHT230802024-03-26
M209230810MTP FUSION PLATE 0 DEGREE, LEFT230812024-03-26
M209230820MTP FUSION PLATE 0 DEGREE, RIGHT230822024-03-26
M209230830MTP FUSION PLATE, NARROW 10 DEGREE, LEFT230832024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177044326Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044333Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044340Signature -x Cement TEKNIMEDLOD2026-01-23
04260102139428OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
03760177040090GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDLOD2025-09-02
03760177043176GENTAFIXTEKNIMEDLOD2025-09-02
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.LOD2025-04-23
08058964729033Arthrex Bone Cement HVG21 SRLLOD2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLLOD2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLLOD2024-09-16
08058964728678BRAVO HVG21 SRLLOD2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLLOD2024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLLOD2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLLOD2024-09-16
08058964729002BRAVO MVG21 SRLLOD2024-09-16
08058964729019BRAVO MV+GG21 SRLLOD2024-09-16
08058964729026BRAVO HV+GG21 SRLLOD2024-09-16
04260056882579BonOs HVOSARTIS GmbHLOD2024-05-17
04260102135338PALACOS®Heraeus Medical GmbHLOD2022-02-13
04260102135376PALACOS®Heraeus Medical GmbHLOD2022-02-13
00815212023484KIT:VCF TREATMENT,RIGHT,FRACTUREIzi Medical Products, LLCLOD2021-10-15
00815212023491KIT:VCF TREATMENT,LEFT,FRACTUREIzi Medical Products, LLCLOD2021-10-15
00815212023507PILOT:GEN A,RIGHTIzi Medical Products, LLCLOD2021-10-15
00815212023514PILOT:GEN A,LEFTIzi Medical Products, LLCLOD2021-10-15
00815212023590KIVA ULTRAFLEX CEMENT NEEDLE KIT Izi Medical Products, LLCLOD2021-10-15
00815212023606KIVA INTRODUCER SETIzi Medical Products, LLCLOD2021-10-15
04260102136120PALACOS®Heraeus Medical GmbHLOD2021-07-15
04260102136168PALACOS®Heraeus Medical GmbHLOD2021-07-15
08031497002316CEMENT KITTECRES SPALOD2021-06-29