FDA.report

NA

Primary DI
34546540857652
Brand
NA
Company
STRYKER CORPORATION
Model
0206521000
Catalog number
0206521000
Device description
Stryker Umbrella Nozzle
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
34546540857652PackageGS16In Commercial Distribution
04546540857651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654085765234546540857652
04546540857651045465408576514546540857651

GMDN Terms

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.

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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