FDA.report

NA

Primary DI
04546540434340
Brand
NA
Company
STRYKER CORPORATION
Model
0306650000
Catalog number
0306650000
Device description
Percutaneous Cement Gun
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications

CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540434340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540434340045465404343404546540434340

GMDN Terms

TermDefinition
Orthopaedic cement/bone filler dispensing gunA hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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