FDA.reportPublic FDA data

NA

Primary DI
04055207040010
Brand
NA
Company
Richard Wolf GmbH
Model
837890
Catalog number
8378.90
Device description
PORTIO CONE ATTACHMENT SZ SMALL for introduction of fluid for hysterosalpingography, curved upwards, compatible with intrauterine probe 8378001, with Luer connection, reusable
Published
2016-09-26
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
HDCTENACULUM, UTERINE
HHISystem, abortion, vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDCTenaculum, UterineObstetrics/Gynecology2
HHISystem, Abortion, VacuumObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207040010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207040010040552070400104055207040010

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide
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
Premarket 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
00850071684162Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684179Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684186Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684193Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684209Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684216Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684223Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00860012999606Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
GYNX31301GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31351GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31300GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31350GynexGYNEX CORPORATIONHHI2023-12-26
04055207040027NARichard Wolf GmbHHHI2022-10-27
M803022721MedGyn Pipette MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022730MedGyn Pipette IV MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022734MedGyn Pipette IIMEDGYN PRODUCTS, INC.HHI2020-12-14
04046955057191AESCULAPAESCULAP, INC.HDC2020-10-19
00821925030862Gyrus ACMIGyrus ACMI, LLCHHI2017-05-10
00821925000247003997-901 Gauze Sack and O-RingGyrus Acmi, Inc.HHI2017-05-10
00821925009561GYRUS ACMIGyrus ACMI, LLCHHI2017-05-09
GYNXLT22500LLETZ Braun TenaculumGYNEX CORPORATIONHDC2017-01-19
10381780177616Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10381780176800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10612479141961McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
10612479143606McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
00821925010475BERKELEYGyrus ACMI, LLCHHI2016-10-18
00821925008632Berkeley 1/2" Collection SetGyrus Acmi, Inc.HHI2016-10-13
00821925008625BERKELEY 1/2" (13mm) PRIMARYGyrus Acmi, Inc.HHI2016-10-13
00821925004184Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 fGyrus Acmi, Inc.HHI2016-10-11
00821925000919VACURETTE CURVED 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11