FDA.reportPublic FDA data

NA

Primary DI
07613327504019
Brand
NA
Company
STRYKER CORPORATION
Model
5407-150-000
Catalog number
5407-150-000
Device description
PI DRIVE 2 MOTOR
Published
2021-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327504019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327504019076133275040197613327504019

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered surgical power tool system motorA compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable 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 Humidity30 Percent (%) Relative Humidity75 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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0018002533210inst.stryker.cs@stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09