FDA.report

AED

Primary DI
00848657016797
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
STZ-WE
Device description
Storz (style) Resectoscope Working Element
Published
2017-06-30
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
FJLRESECTOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657016797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657016797008486570167978486570167970848657016797

GMDN Terms

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
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

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Other Devices Sharing Product Codes

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04055207071724PIRANHARichard Wolf GmbHFJL2025-11-17
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00848657077507AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2025-08-25
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00860011104445VeloxionAulea Medical Inc.FJL2025-01-03
00860011104452VeloxionAulea Medical Inc.FJL2025-01-03
04055207069936NARichard Wolf GmbHFJL2024-08-19
04055207069783NARichard Wolf GmbHFJL2024-04-01
04055207057322SHARKRichard Wolf GmbHFJL2024-03-29
04055207055106PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207055113PANOVIEWRichard Wolf GmbHFJL2023-08-03
04055207065464NARichard Wolf GmbHFJL2020-02-24
04055207065471NARichard Wolf GmbHFJL2020-02-24
04055207065488NARichard Wolf GmbHFJL2020-02-24
04055207065495NARichard Wolf GmbHFJL2020-02-24
00848657068536AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657070423AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657085519AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
00848657087056AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FJL2019-06-13
04055207028063E-LINERichard Wolf GmbHFJL2018-06-11
04059082031873UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031880UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
04059082031897UreterorenoscopeSOPRO-COMEG GmbHFJL2018-03-20
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