FDA.reportPublic FDA data

AED

Primary DI
00848657077491
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
HW5410
Device description
HYSTERO RESECTOSCOPE WORKING ELEMENT
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDCRESECTOSCOPE, WORKING ELEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657077491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657077491008486570774918486570774910848657077491

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207063200ERAGONRichard Wolf GmbHFDC2025-10-20
03665415002840Active working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002857Passive working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002888Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatLAMIDEY NOURY MEDICALFDC2025-10-08
03665415002895Active working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatiLAMIDEY NOURY MEDICALFDC2025-10-08
03665415002772Bipolar cutting loop / SLIM (round; Fr22)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002796Active working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002802Passive working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
04048438000175NAKarl Storz GmbH & Co. KGFDC2025-03-27
04048438005408n.a.Karl Storz GmbH & Co. KGFDC2024-10-04
04055207056691NARichard Wolf GmbHFDC2024-03-29
04055207056707NARichard Wolf GmbHFDC2024-03-29
04055207057247NARichard Wolf GmbHFDC2024-03-29
04055207057254NARichard Wolf GmbHFDC2024-03-29
04055207057261NARichard Wolf GmbHFDC2024-03-29
04055207057278NARichard Wolf GmbHFDC2024-03-29
04055207057285NARichard Wolf GmbHFDC2024-03-29
04055207057292NARichard Wolf GmbHFDC2024-03-29
04055207057308NARichard Wolf GmbHFDC2024-03-29
04055207057315NARichard Wolf GmbHFDC2024-03-29
04055207057339SHARKRichard Wolf GmbHFDC2024-03-29
00848657018951WA22507D BIPOLAR LOOP 24FR LARGE - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657018982WA22306D BIPOLAR LOOP 24FR - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019019AED-WA22355C BIPOLAR NEEDLE ELECTRODE 24FR - ANGLE TIPNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019033AED-WA22557C BUTTON ELECTRODE - BIPOLAR 24FR - 90 DEGREE - PLASMANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFDC2023-04-21