FDA.reportPublic FDA data

NA

Primary DI
04055207023655
Brand
NA
Company
Richard Wolf GmbH
Model
8983201
Catalog number
8983.201
Device description
INSTRUMENT PORT
Published
2017-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEWCuldoscope (and accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207023655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207023655040552070236554055207023655

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceAPPLIED MEDICAL RESOURCES CORPORATIONHEW2026-04-22
19349967004996ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
19349967005009ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967004993ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967005006ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
10607915145313GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145320GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145337GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915146693GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
00607915145613GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-02-17
00888937015737Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015744Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015751Koh CupCoopersurgical, Inc.HEW2022-12-01
20888937015700Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015717Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015724Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
00888937015065RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015072RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015089RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015096RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015102RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015119RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015126RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015133RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015140Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015157Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015164Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015171Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015188Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015195Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10