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
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVDZJ2026-10-20
00888118155498IPSKLS-Martin L.P.DZJ2026-09-28
00888118155504IPSKLS-Martin L.P.DZJ2026-09-28
00888118155511IPSKLS-Martin L.P.DZJ2026-09-28
00888118155528IPSKLS-Martin L.P.DZJ2026-09-28
00888118155535IPSKLS-Martin L.P.DZJ2026-09-28
00888118155542IPSKLS-Martin L.P.DZJ2026-09-28
00888118155559IPSKLS-Martin L.P.DZJ2026-09-28
00888118155566IPSKLS-Martin L.P.DZJ2026-09-28
00860015267801EmbedMed3D LIFEPRINTS UK LTDDZJ2026-03-30
00860012759446TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759453TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759460TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
05420060380747TRUMATCHMaterialise NVDZJ2025-02-28
00860012759408TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759415TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759422TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860011469285TECHFITTechfit Digital Surgery, Inc.DZJ2024-08-28
00860011469261TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469278TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469216TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469223TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469230TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
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