FDA.reportPublic FDA data

NA

Primary DI
07613327291483
Brand
NA
Company
STRYKER MEDTECH K.K.
Model
5450800024
Catalog number
5450-800-024
Device description
Torque Wrench, 1.96 Nm - 7 mm
Published
2018-09-24
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327291483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327291483076133272914837613327291483

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system torque wrench, reusableA hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a reusable device.

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
690682147
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327290202NA54508250005450-825-0002016-09-23
07613327291803NA54508040005450-804-0002018-09-24
07613327291827NA54508060005450-806-0002018-09-24
07613327291872Sonopet54508500005450-850-0002018-09-24
07613327291933NA54508400005450-840-0002018-09-24
07613327291940NA54508500075450-850-0072018-09-24
07613327291919NA54508200005450-820-0002018-09-24
07613327289886NA54508000405450-800-0402016-09-23
07613327289893Hyper LT54508140005450-814-0002018-09-24
07613327291537NA54508002765450-800-2762018-09-24
07613327291520NA54508000385450-800-0382018-09-24
07613327291490NA545080003054508000302018-09-24
07613327291568NA545080002954508000292018-09-24
07613327291575NA545080002554508000252018-09-24
07613327291896NA54508500285450-850-0282018-09-24
07613327291957Hyper LT54508110005450-811-0002018-09-24

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00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
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