FDA.report

n.a.

Primary DI
04048551390238
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27023LD
Device description
Stone Basket, 2.5 Fr., w/o tip, straight
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551390238PrimaryGS10
04048551390245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551390238040485513902384048551390238
04048551390245040485513902454048551390245

GMDN Terms

TermDefinition
Biliary stone retrieval basketA manual instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate biliary stones for the treatment of conditions such as cholelithiasis (i.e., presence of calculi in the bile duct or gallbladder). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is typically used in a procedure such as an endoscopic retrograde cholangiopancreatography (ERCP) or a laparoscopic cholecystectomy. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
3
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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