FDA.reportPublic FDA data

PowerFlo

Primary DI
00889024516243
Brand
PowerFlo
Company
Zimmer, Inc.
Model
SSI004630A0
Catalog number
SSI004630A0
Published
2018-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00889024516243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024516243008890245162438890245162430889024516243

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1 (800) 343-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

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