FDA.reportPublic FDA data

NA

Primary DI
10886982130143
Brand
NA
Company
Synthes GmbH
Model
05.001.231
Catalog number
05001231
Device description
LID FOR HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM
Published
2016-12-31
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
MOQBATTERY, REPLACEMENT, RECHARGEABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOQBattery, Replacement, RechargeableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819474901Direct MarkingGS10
10886982130143PrimaryGS10
H679050012310SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819474901076118194749017611819474901
1088698213014310886982130143

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800079000060K2 Lithium-ion batteryHULASER, Inc.MOQ2026-07-29
00810179320973AnybatteryANYBATTERY, INCMOQ2026-07-07
06934726614453Battery PackLongfian Scitech Co., Ltd.MOQ2026-04-25
30845854052079HALLConmed CorporationMOQ2026-04-01
00819595011175Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015029Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015661Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015685Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015692Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015876Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015906Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595015944Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016040Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016118Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016125Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016149Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016163Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016750Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016781Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016828Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016880Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016897Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016910Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016934Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016941Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016958Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016965Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595016972Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017092Artisan PowerArtisan Power LLCMOQ2026-02-10
00819595017108Artisan PowerArtisan Power LLCMOQ2026-02-10