FDA.reportPublic FDA data

SHARK/S-LINE

Primary DI
04055207066102
Brand
SHARK/S-LINE
Company
Richard Wolf GmbH
Model
46230223US
Catalog number
46230223US
Device description
COAG ELECTRODE BIPO 24-26FR 12/30°
Published
2023-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207066102PrimaryGS10
04055207066119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207066102040552070661024055207066102
04055207066119040552070661194055207066119

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONFAS2016-09-23
07613327053791NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONHIH2016-09-23
07613327053814NASTRYKER CORPORATIONFAS2016-09-23
07613327053814NASTRYKER CORPORATIONHIH2016-09-23
07613327053821NASTRYKER CORPORATIONHIH2016-09-23
07613327053845NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONFAS2016-09-23
07613327053869NASTRYKER CORPORATIONHIH2016-09-23
07613327053869NASTRYKER CORPORATIONFAS2016-09-23
07613327053876NASTRYKER CORPORATIONHIH2016-09-23