FDA.report

Wellead Stone Retrieval Basket

Primary DI
16936881136822
Brand
Wellead Stone Retrieval Basket
Company
Well Lead Medical Co.,Ltd
Model
U04B010810
Device description
SB4NS-18120
Published
2023-07-12
Public version status
New
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
FFLDislodger, Stone, Basket, Ureteral, Metal

Product Code Classifications

CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16936881136822PackageGS11In Commercial Distribution
26936881136829PackageGS110In Commercial Distribution
06936881136825PrimaryGS10

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
544811862
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
true
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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16925816657525ClearPetraU04A1011262026-01-26
16925816657532ClearPetraU04A1012262026-01-26
16925816657549ClearPetraU04A1013262026-01-26
16925816657556ClearPetraU04A1010362026-01-26
16925816657563ClearPetraU04A1011362026-01-26
16925816657570ClearPetraU04A1012362026-01-26
16925816657587ClearPetraU04A1013362026-01-26
16925816657594ClearPetraU04A1010402026-01-26
16925816657600ClearPetraU04A1011402026-01-26
16925816657617ClearPetraU04A1012402026-01-26
16925816657624ClearPetraU04A1013402026-01-26
16925816657631ClearPetraU04A1010462026-01-26
16925816657648ClearPetraU04A1011462026-01-26
16925816657655ClearPetraU04A1012462026-01-26
16925816657662ClearPetraU04A1013462026-01-26
16925816657679ClearPetraU04A1010502026-01-26

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00810143891317Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
B0325550200HaloSACRED HEART MEDICAL,INC.FFL2024-07-18
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03600040955598DormiaColoplast A/SFFL2024-04-05
03600040955659Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
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16936881150095Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
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