FDA.reportPublic FDA data

NA

Primary DI
04055207011911
Brand
NA
Company
Richard Wolf GmbH
Model
2228801
Catalog number
2228.801
Device description
CHIP COLLECTING CONTAINER for hysteroscopy, for the suction of tissue during resection, max. suction power 750mbar
Published
2024-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJLResectoscope
HIHHYSTEROSCOPE (AND ACCESSORIES)
KQTEvacuator, gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207011911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207011911040552070119114055207011911

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327055313NASTRYKER CORPORATIONKQT2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONKQT2016-09-23
07613327055405NASTRYKER CORPORATIONKQT2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONKQT2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055542Rev360STRYKER CORPORATIONKQT2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONKQT2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONKQT2016-09-23
07613327061475AHTOSTRYKER CORPORATIONKQT2016-09-23
07613327061499AHTOSTRYKER CORPORATIONKQT2016-09-23
07613327061659AHTOSTRYKER CORPORATIONKQT2016-09-23
07613327053777NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONKQT2016-09-23
07613327053791NASTRYKER CORPORATIONKQT2016-09-23
07613327053807NASTRYKER CORPORATIONHIH2016-09-23
07613327053814NASTRYKER CORPORATIONHIH2016-09-23
07613327053821NASTRYKER CORPORATIONKQT2016-09-23
07613327053821NASTRYKER CORPORATIONHIH2016-09-23
07613327053845NASTRYKER CORPORATIONHIH2016-09-23