FDA.reportPublic FDA data

PCD

Primary DI
04546540518095
Brand
PCD
Company
STRYKER CORPORATION
Model
0506486000
Catalog number
0506486000
Device description
Precision System without Needle
Published
2018-09-24
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
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540518096PackageGS14In Commercial Distribution
04546540518095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654051809634546540518096
04546540518095045465405180954546540518095

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic cement mixer, reusableA hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16
07613327662047ALPHAVENT3911-856-5553911-856-5552025-06-16
07613327662054ALPHAVENT3911-856-5653911-856-5652025-06-16
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23
07613154757091VertaPlex04064020000406-402-0002016-06-30
07613327141764VertaPlex04064020020406-402-0022016-09-23
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327170566VertaPlex04064020150406-402-0152016-09-23
00808232000214NA2102-01312102-01312015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
00840456203163JMUJMU DENTAL, INCJDZ2026-08-18
00840456207123JMUJMU DENTAL, INCJDZ2026-08-18
00840456207130JMUJMU DENTAL, INCJDZ2026-08-18
00840456223628JMUJMU DENTAL, INCJDZ2026-08-18
00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
00884450587713StabiliT®Merit Medical Systems, Inc.OAR2026-07-30
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOAR2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOAR2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOAR2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOAR2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOAR2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOAR2025-12-17
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
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
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20