FDA.report

AED

Primary DI
00848657016841
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
32-4205
Device description
Resectoscope Sheath for Continuous Irrigation with Standard Obturator 24FR
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
00848657016841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657016841008486570168418486570168410848657016841

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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