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
04055207000649NA799000179900012021-04-05
04055207000656NA799000279900022021-04-05
04055207058862NA799000379900032021-04-05
04055207070055NA10300103.002024-06-03
04055207058886NA82295822952022-08-09
04055207038758FUSION DESIGN8095098095092022-03-08
04055207055199FUSION DESIGN8070028070022022-03-08
04055207065730VERTEBRIS1520826415208.2642022-11-01
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551455ProxivaShenzhen Trious Medical Technology Co., LtdKQT2026-08-18
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
06973356551721TriousShenzhen Trious Medical Technology Co., LtdKQT2026-06-23
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
00821925001862USA SeriesGyrus ACMI, LLCHIH2016-10-14
00821925002081USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925002524USA SeriesGyrus ACMI, LLCHIH2016-10-14
00821925002739USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003668USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003675USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003682USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003699USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003712USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925003736USA EliteGyrus ACMI, LLCHIH2016-10-14
00821925001480USA EliteGyrus ACMI, LLCHIH2016-10-13
00821925001497USA EliteGyrus ACMI, LLCHIH2016-10-13
00821925001602Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001626Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001633Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001657Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001664Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001671Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001688Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001695Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13
00821925001701Elite 2 SystemGyrus ACMI, LLCHIH2016-10-13