FDA.reportPublic FDA data

TPX

Primary DI
07613327652772
Brand
TPX
Company
STRYKER CORPORATION
Model
7200008000
Catalog number
7200-008-000
Device description
HD Handpiece
Published
2026-04-13
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327652772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327652772076133276527727613327652772

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motor, electricA hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius40 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
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810007633343AccuPlan SystemMedcadDZJ2025-10-31
00810007633350AccuPlan SystemMedcadDZJ2025-10-31
00810007633367AccuPlan SystemMedcadDZJ2025-10-31
00810007633374AccuPlan SystemMedcadDZJ2025-10-31
00810007633381AccuPlan SystemMedcadDZJ2025-10-31
00810007633336AccuPlan System MedcadDZJ2025-10-30
00840124524255FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00840124524262FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00810007633183AccuPlan System MedcadDZJ2024-10-18
00810007633190AccuPlan System MedcadDZJ2024-10-18
00810007633213AccuPlan System MedcadDZJ2024-10-18
00810007633220AccuPlan System MedcadDZJ2024-10-18
00810007633237AccuPlan System MedcadDZJ2024-10-18
00810007631547AccuPlan SystemMedcadDZJ2023-11-30
00810007632209AccuPlan SystemMedcadDZJ2023-11-02
00810007632223AccuPlan SystemMedcadDZJ2023-11-02
00810007631202AccuPlan System MedcadDZJ2023-11-01
00810007631257AccuPlan System MedcadDZJ2023-11-01
00810007631264AccuPlan SystemMedcadDZJ2023-11-01
00810007631561AccuPlan SystemMedcadDZJ2023-11-01
00810007631677AccuPlan System MedcadDZJ2023-11-01
00810007631813AccuPlan System MedcadDZJ2023-11-01
00810007631820AccuPlan System MedcadDZJ2023-11-01
00810007631851AccuPlan System MedcadDZJ2023-11-01
00810007631875AccuPlan System MedcadDZJ2023-11-01
00810007631905AccuPlan System MedcadDZJ2023-11-01
00810007631912AccuPlan System MedcadDZJ2023-11-01
00810007631929AccuPlan System MedcadDZJ2023-11-01
00810007631936AccuPlan System MedcadDZJ2023-11-01
00810007631950AccuPlan System MedcadDZJ2023-11-01