FDA.reportPublic FDA data

CEMENT NOZZLE

Primary DI
00880304370456
Brand
CEMENT NOZZLE
Company
Biomet Orthopedics, LLC
Model
414991
Catalog number
414991
Published
2017-07-28
Public version status
Update
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
KIHDISPENSER, CEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIHDispenser, CementOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304370456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304370456008803043704568803043704560880304370456

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053617183750PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183767PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183774PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183781PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183798PressurizerADLER ORTHO SPAKIH2025-08-07
08053617183804PressurizerADLER ORTHO SPAKIH2025-08-07
08053617184498PressurizerADLER ORTHO SPAKIH2025-08-07
06951233720842PALAGUN®Guangzhou Clean Medical Products Manufacturing Corp.KIH2025-06-05
00763000883461N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883478N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000883485N/aMEDTRONIC SOFAMOR DANEK, INC.KIH2025-06-01
00763000242510MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2025-05-11
25060238201630HiVac™ 7 Triple Mix SUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201654HiVac™ 7 with Femoral Cement Pressuriser SUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201678HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201685HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
250602382017159mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201777Cement Mixing and Delivery SystemSUMMIT MEDICAL LIMITEDKIH2025-01-10
25060238201807MiniMix™ Delivery SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
00763000711993N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712006N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712013N/AMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
00763000712020n/aMEDTRONIC SOFAMOR DANEK, INC.KIH2024-12-28
08058964726841Flex FillerG21 SRLKIH2024-10-10
250602382016096mm Slim Flexible NozzleSUMMIT MEDICAL LIMITEDKIH2024-05-22
25060238201616HiVac™ 7SUMMIT MEDICAL LIMITEDKIH2024-05-20
08800104078415AnyPlus®GS Medical Co., Ltd.KIH2024-05-02
25060238201357SmartMix™ Vacuum SyringeSUMMIT MEDICAL LIMITEDKIH2024-04-26
25060238201364SmartMix™ Vacuum Syringe PlusSUMMIT MEDICAL LIMITEDKIH2024-04-26
25060238201418SmartMix™ Syringe KitSUMMIT MEDICAL LIMITEDKIH2024-04-26