FDA.reportPublic FDA data

NA

Primary DI
10886982129635
Brand
NA
Company
Synthes GmbH
Model
05.001.202
Catalog number
05001202
Device description
POWER MODULE 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
07611819977822Direct MarkingGS10
10886982129635PrimaryGS10
H679050012020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819977822076118199778227611819977822
1088698212963510886982129635

GMDN Terms#

Term, Definition table
TermDefinition
Portable/mobile rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). 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
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00819595017115Artisan PowerArtisan Power LLCMOQ2026-02-10