FDA.reportPublic FDA data

Sonopet iQ

Primary DI
37613327422499
Brand
Sonopet iQ
Company
STRYKER CORPORATION
Model
550025B114
Catalog number
5500-25B-114
Device description
11cm iQ Apex Knife
Published
2019-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFLInstrument, ultrasonic surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327422499PackageGS14In Commercial Distribution
07613327422498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332742249937613327422499
07613327422498076133274224987613327422498

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical system handpiece tipA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
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 Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603515776SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515783SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515790SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515806SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515837SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515844SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515851SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515868SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515875SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515882SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515899SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515905SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515912SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515929SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515936SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515943SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515950SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515967SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515974SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515981SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603515998SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516001SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516018SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516025SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516032SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516049SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516056SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603516063SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603519248SMTPSMTP Medical Co., Ltd.LFL2025-09-24
06972603519255SMTPSMTP Medical Co., Ltd.LFL2025-09-24