FDA.reportPublic FDA data

TPS

Primary DI
04546540983930
Brand
TPS
Company
STRYKER CORPORATION
Model
5100131000
Catalog number
5100-131-000
Device description
XL Oscilliating Saw
Published
2018-09-23
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
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032117000STRYKER TOTAL PERFORMANCE (TPS) SYSTEMStryker Instruments2003-08-08DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540983930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540983930045465409839304546540983930

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
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
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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