FDA.report

PCD SpinePlex

Primary DI
34546540434396
Brand
PCD SpinePlex
Company
STRYKER CORPORATION
Model
0505585000
Catalog number
0505-585-000
Device description
Precision System with Needle/ Radiopaque Bone Cement
Published
2015-09-24
Public version status
Update
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
LODBONE CEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540434396PackageGS14In Commercial Distribution
04546540434395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654043439634546540434396
04546540434395045465404343954546540434395

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 Gauge13Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 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
false
HCT/P
false
Kit
true
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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