FDA.report

Sonopet iQ

Primary DI
37613327298636
Brand
Sonopet iQ
Company
STRYKER CORPORATION
Model
5500573000
Catalog number
5500-573-000
Device description
Irrigation Suction Cassette
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LFLInstrument, ultrasonic surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613327298636PackageGS14In Commercial Distribution
07613327298635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761332729863637613327298636
07613327298635076133272986357613327298635

GMDN Terms

TermDefinition
Ultrasonic surgical system tubing setA sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+0018002533210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
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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