FDA.reportPublic FDA data

Disposable Transbronchial Needle

Primary DI
00813353010288
Brand
Disposable Transbronchial Needle
Company
Telemed Systems
Model
2102
Device description
Sure-Stop Transbronchial Aspiration Needle21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K901438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901438000SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLETelemed Systems, Inc.1990-05-24GAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813353010288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813353010288008133530102888133530102880813353010288

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

Regulatory Flags#

DUNS number
017939239
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813353010080Disposable Sure-Flex Biliary Balloon Dilatation Catheter13422023-07-12
00813353010097Disposable Sure-Flex Biliary Balloon Dilatation Catheter13442023-07-12
00813353010103Disposable Sure-Flex Biliary Balloon Dilatation Catheter13462023-07-12
00813353010110Disposable Progressive Pressure Dilators14152023-07-12
00813353010127Disposable Progressive Pressure Dilators14182023-07-12
00813353010196Disposable Sclerotherapy Needle20022023-08-24
00813353010202Disposable Sclerotherapy Needle20042023-08-24
00813353010219Disposable Sclerotherapy Needle20062023-08-24
00813353010226Disposable Sclerotherapy Needle20082023-08-24
00813353010233Disposable Sclerotherapy Needle20102023-08-24
00813353010240Disposable Sclerotherapy Needle20142023-08-24
00813353010257Disposable Sclerotherapy Needle20152023-08-24
00813353010264Disposable Sclerotherapy Needle20162023-08-24
00813353010271Disposable Sclerotherapy Needle20182023-08-24
00813353010295Disposable Gastrointestinal Cytology Brush30022023-08-24
00813353010301Disposable Gastrointestinal Cytology Brush30042023-08-24
00813353010318Disposable Gastrointestinal Cytology Brush30062023-08-24
00813353010325Disposable Gastrointestinal Cytology Brush30082023-08-24
00813353010332Disposable Gastrointestinal Cytology Brush30102023-08-24
00813353010349Disposable Gastrointestinal Cytology Brush30122023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144017596Metier MedicalMETIER MEDICAL LTDGAA2026-10-19
00860015723901NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723918NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723925NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723932NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020190InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09
00817295020374InradInradGAA2026-10-09
00817295020381InradInradGAA2026-10-09
00817295020398InradInradGAA2026-10-09