FDA.report

NA

Primary DI
34546540184697
Brand
NA
Company
STRYKER CORPORATION
Model
0207058000
Catalog number
0207058000
Device description
Multiple-Orifice Tip
Published
2016-09-23
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
FQHLAVAGE, JET

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540184697PackageGS112In Commercial Distribution
04546540184696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654018469734546540184697
04546540184696045465401846964546540184696

GMDN Terms

TermDefinition
Surgical irrigation handpiece nozzleA sterile device designed to be attached to the distal end of a lavage system or kit handpiece to function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site. It is available in many designs, shapes and sizes, including a fan spray, shower spray, high capacity with multiple aperture spray; some have a built-in filter, splash shield, or brush. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage 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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