FDA.reportPublic FDA data

Revolution

Primary DI
07613154170982
Brand
Revolution
Company
STRYKER CORPORATION
Model
0606520000
Catalog number
0606-520-000
Device description
MIS Breakaway Nozzle
Published
2018-09-24
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
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
37613154170983PackageGS16In Commercial Distribution
07613154170982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315417098337613154170983
07613154170982076131541709827613154170982

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement injection cannulaA sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use 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
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
00850024195134MOLLIMS-00009MM10122022-06-27
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327624069EchoECHO100100-01ECHO100100-012025-01-24
07613327624083EchoECHO100105-01ECHO100105-012025-01-24
07613327624106Broadway 8BRW084132-01BRW084132-012025-01-24
07613327561210Stroke Fast PackAXS2PK07404601AXS2PK074046012023-07-14
07613327561227Stroke Fast PackAXS2PK07104601AXS2PK071046012023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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