FDA.report

SURLOK Helical Stone Basket 3.0 FR (1.0 mm) X 90 cm Basket Width: 11

Primary DI
00821925010246
Brand
SURLOK Helical Stone Basket 3.0 FR (1.0 mm) X 90 cm Basket Width: 11
Company
Gyrus Acmi, Inc.
Model
5700005
Published
2016-10-03
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
FGODISLODGER, STONE, FLEXIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
FGODislodger, Stone, FlexibleGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925010246PrimaryGS10

GMDN Terms

TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). 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 used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
true
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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