FDA.reportPublic FDA data

SMALL DIAMETER CEMENT PLUG INSERTER

Primary DI
00880304561618
Brand
SMALL DIAMETER CEMENT PLUG INSERTER
Company
Biomet Orthopedics, LLC
Model
414989
Catalog number
414989
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00880304561618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304561618008803045616188803045616180880304561618

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant holder, single-useA sterile hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24
00880304434370Vanguard® Knee System1842811842812015-10-24

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