DEVICE: FlexStone Basket (G380FSA120210)

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Device Record History
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Device Identifier (DI) Information
FlexStone Basket
FSA-120-21
In Commercial Distribution

EndoTheia, Inc.
G380FSA120210
HIBCC

1
081343728 *Terms of Use
Single-Use Steerable Basket
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44333 Urinary stone retrieval basket, single-use
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FFL Dislodger, Stone, Basket, Ureteral, Metal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
c8ae4fef-d7c4-4d69-8e1c-ab17a7ac8846
April 24, 2025
1
April 16, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
G380FSA120211 1 G380FSA120210 In Commercial Distribution
G380FSA120212 4 G380FSA120211 In Commercial Distribution Shipper Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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