FDA.reportPublic FDA data

Hobbs Medical Transbronchial Aspiration Needle

Primary DI
M84946210
Brand
Hobbs Medical Transbronchial Aspiration Needle
Company
HOBBS MEDICAL, INC.
Model
4621
Catalog number
4621
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860582000TBI NEEDLEHobbs Medical, Inc.1986-03-04GAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M84946210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8606845875customerservice@hobbsmedical.com

Regulatory Flags#

DUNS number
076769355
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M84921890CleanCapture Aspiration Catheter218921892026-01-14
M84921891CleanCapture Aspiration Catheter218921892026-01-14
M84960050Hobbs Biliary Amsterdam Stent Kit600560052016-09-21
M84960060Hobbs Biliary Amsterdam Stent Kit600660062016-09-21
M84960090Hobbs Biliary Amsterdam Stent Kit600960092016-09-21
M84960110Hobbs Biliary Amsterdam Stent Kit601160112016-09-21
M84960120Hobbs Biliary Amsterdam Stent Kit601260122016-09-21
M84960130Hobbs Biliary Amsterdam Stent Kit601360132016-09-21
M84960140Hobbs Biliary Amsterdam Stent Kit601460142016-09-21
M84960150Hobbs Biliary Amsterdam Stent Kit601560152016-09-21
M84963100Freeman Pancreatic Flexi-Stent Kit631063102016-09-21
M84963110Freeman Pancreatic Flexi-Stent Kit631163112016-09-21
M84963200Freeman Pancreatic Flexi-Stent Kit632063202016-09-21
M84963210Freeman Pancreatic Flexi-Stent Kit632163212016-09-21
M84965010Freeman Pancreatic Flexi-Stent Kit650165012016-09-21
M84965020Freeman Pancreatic Flexi-Stent Kit650265022016-09-21
M84965030Freeman Pancreatic Flexi-Stent Kit650365032016-09-21
M84965040Freeman Pancreatic Flexi-Stent Kit650465042016-09-21
M84965050Freeman Pancreatic Flexi-Stent Kit650565052016-09-21
M84965060Freeman Pancreatic Flexi-Stent Kit650665062016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956573604CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-25
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00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
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