FDA.report

AutoPlex

Primary DI
34546540593109
Brand
AutoPlex
Company
STRYKER CORPORATION
Model
0605887000
Catalog number
0605887000
Device description
System without Needles and Cement
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
34546540593109PackageGS12In Commercial Distribution
04546540593108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654059310934546540593109
04546540593108045465405931084546540593108

GMDN Terms

TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius40 Degrees Celsius

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

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Primary DIBrandCompanyProduct codePublished
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25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
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25060238201784 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
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08058964728753Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
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