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 implantable material dispenser, reservoir-containingA non-powered, syringe-/pipette-like device intended to load orthopaedic cement and/or a bone void filling material (not included) within an included reservoir/barrel and dispense the material during surgery. It is not designed to accept a separate cartridge/syringe or prepare/mix the substance. It may be intended to be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

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
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150081073Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.KIH2026-07-30
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAKIH2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAKIH2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAKIH2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAKIH2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAKIH2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAKIH2025-12-17
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KIH2025-10-23
08053617184450PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184467PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184474PressurizerADLER ORTHO SPAKIH2025-10-07
08053617184481PressurizerADLER ORTHO SPAKIH2025-10-07
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
15060238201633HiVac™ 7 Triple Mix SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser SUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201671HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
15060238201688HiVac™ SyringeSUMMIT MEDICAL LIMITEDKIH2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderSUMMIT MEDICAL LIMITEDKIH2025-01-10