FDA.reportPublic FDA data

Nephrostomy introduction Needle Diamond Tip

Primary DI
16936881156561
Brand
Nephrostomy introduction Needle Diamond Tip
Company
Well Lead Medical Co.,Ltd
Model
U01A030218
Device description
18G x 20cm echogenic tip
Published
2022-12-08
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

Product Codes#

Code, Name table
CodeName
GBOCatheter, Nephrostomy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936881156561PackageGS15In Commercial Distribution
26936881156568PackageGS110In Commercial Distribution
06936881156564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693688115656116936881156561
2693688115656826936881156568
06936881156564069368811565646936881156564

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16925816667210ClearPetraU04A1010262026-03-16
16925816667227ClearPetraU04A1011262026-03-16
16925816667234ClearPetraU04A1012262026-03-16
16925816657518ClearPetraU04A1010262026-01-26
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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Primary DI, Brand, Company table
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25051684011614Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011621Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011638Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011645Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011652Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011669Total AbscessionAngiodynamics, Inc.GBO2024-10-30
04046955638406ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638581ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
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04046955639205ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
10812261012282allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
16936881156578Nephrostomy introduction Needle Diamond TipWell Lead Medical Co.,LtdGBO2022-12-08
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