AccessGUDID - DEVICE: Sonopet iQ (07613327298611)

GUDID

Device Identifier (DI) Information

Brand Name: Sonopet iQ
Version or Model: 5500255000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5500-255-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327298611
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Universal Angled Handpiece

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63967	Hard/soft-tissue ultrasonic surgical system handpiece	A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current into an ultrasonic oscillation, and transfer the energy to an attachable tip, to mechanically fragment and cut both bone and soft-tissue cells upon contact (depending on the type of tip attached) during multiple types of surgery: it is not dedicated exclusively to dental applications. It typically includes cables for power supply and tubing to circulate cooling fluid to the attachable tip. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 27 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 611ebbc8-4414-4ee2-bdc2-f43b4abfc6f9
Public Version Date: May 07, 2019
Public Version Number: 2
DI Record Publish Date: April 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +0018002533210
Email: Inst.Stryker.cs@Stryker.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES