FDA.reportPublic FDA data

Power-Flo®

Primary DI
00889024374850
Brand
Power-Flo®
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-5049-045-01
Catalog number
00-5049-045-01
Published
2019-03-08
Public version status
New
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
JDZMIXER, CEMENT, FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024374850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024374850008890243748508890243748500889024374850

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic cement mixer, single-useA sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
137354267
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
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
06934415056632ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
06934415056649ZKSKBeijing ZKSK Technology Co.,LtdJDZ2026-05-18
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
03701505801211DynamoTEKNIMEDJDZ2026-02-02
03701505801228DynamoTEKNIMEDJDZ2026-02-02
03701505801235DynamoTEKNIMEDJDZ2026-02-02
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDJDZ2025-03-31
03701505801075PUREKIT SyringesTEKNIMEDJDZ2025-03-31
03701505800498PureKit Syringe 4cc MVTEKNIMEDJDZ2025-03-31
15060238201725Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201732Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201749HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201756Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201722Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201739Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201746HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201753Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201784 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201791MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201883Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONJDZ2024-11-21
07613327547535AutoPlex M4STRYKER CORPORATIONJDZ2024-11-21