FDA.report

AED

Primary DI
00848657016872
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
32-4420
Device description
Strauss Penile Clamp
Published
2017-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657016872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657016872008486570168728486570168720848657016872

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
00848657078269AEDJZM15922026-03-02
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23
00848657069243AED67161D2026-01-23
00848657069250AED67161FZ2026-01-23
00848657069618AEDA24136-472026-01-23
00848657074889AED2717452026-01-23
00848657075060AED020-017-2200H2026-01-23
00848657075084AED27174T2026-01-23
00848657075244AED2717432026-01-23
00848657075725AEDAED27425ZG2026-01-23
00848657076289AEDAED27023FG2026-01-23
00848657076692AEDA24131-472026-01-23
00848657078160AEDAED27023ZE2026-01-23
00848657078177AEDAED 27174P2026-01-23
00848657078184AEDA24126-472026-01-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850006759842Aveta Tissue Catch with TubingMEDITRINA, INC.HIH2026-03-20
16973672291155ARMIJiangsu Jiyuan Medical Technology Co .,Ltd.HIH2026-01-23
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
04048551274712NAKarl Storz GmbH & Co. KGHIH2025-03-27
04048551274729NAKarl Storz GmbH & Co. KGHIH2025-03-27
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