FDA.reportPublic FDA data

NA

Primary DI
04055207023662
Brand
NA
Company
Richard Wolf GmbH
Model
8986251
Catalog number
8986.251
Device description
HANDLE FOR HYSTEROSCOPE compatible with sheath system for diagnostic hysteroscopy, bayonet-cap, reusable
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207023662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207023662040552070236624055207023662

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization
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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

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Primary DI, Brand, Company table
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16973672291162ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291179ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
16973672291186ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
06973672291196ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
00848657077439AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077514AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077521AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077545AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
00848657077569AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.HIH2025-08-25
26974880991445HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880991452HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
06974880991632HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
26974880993401HTx Disposable HysteroscopeSuzhou AcuVu medical technology Co., Ltd.HIH2025-05-08
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04048551274736NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551367537NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551418284NAKarl Storz GmbH & Co. KGHIH2025-03-27
00821925002487USA Elite SystemGyrus ACMI, LLCHIH2024-11-27
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
15420045516113Fluent Pro Waste BagHologic, Inc.HIH2024-10-15
15420045516137Fluent Pro Tissue TrapHologic, Inc.HIH2024-10-15
00850006759705Aveta Waste Management AccessoryMEDITRINA, INC.HIH2024-10-14
10850006759733Aveta Waste Bag with Tissue CatchMEDITRINA, INC.HIH2024-10-14
00850033976250HERizon Medical Endoscope Image Processor Minerva Surgical, Inc.HIH2024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeMinerva Surgical, Inc.HIH2024-10-07
04048551390405n.a.Karl Storz GmbH & Co. KGHIH2019-02-23
04048551083451n.a.Karl Storz GmbH & Co. KGHIH2018-08-21