FDA.report

PCD

Primary DI
34546540907012
Brand
PCD
Company
STRYKER CORPORATION
Model
0506483000
Catalog number
0506483000
Device description
Precision System with 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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDZMIXER, CEMENT, FOR CLINICAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540907012PackageGS14In Commercial Distribution
04546540907011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654090701234546540907012
04546540907011045465409070114546540907011

GMDN Terms

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.

Device Sizes

TypeValueUnit
Needle Gauge11Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
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 DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
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
08058964723758Disp. Mixing Bowl-OG21 SRLJDZ2024-10-14
08058964728654Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlG21 SRLJDZ2024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729057Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964724564PicoMix VG21 SRLJDZ2024-10-10
08058964724670PicoMix BowlG21 SRLJDZ2024-10-10
08058964725042PicoMix SyringeG21 SRLJDZ2024-10-10
08058964726261PicoMix SyringeG21 SRLJDZ2024-10-10
08058964727831PicoMix BowlG21 SRLJDZ2024-10-10
08058964727848PicoMix SyringeG21 SRLJDZ2024-10-10
06951233721610CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721634CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721658CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721665CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721672CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721696CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721719CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15