FDA.reportPublic FDA data

PneumoDart

Primary DI
00855204008167
Brand
PneumoDart
Company
TyTek Medical Inc.
Model
TM-317
Catalog number
TM-317
Device description
Superior Tension Pneumothorax Decompression Needle
Published
2019-10-03
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855204008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855204008167008552040081678552040081670855204008167

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078589992
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010987902Surgical HypoHolder10032025-06-27
00860010987940Clinical HypoHolder10042025-06-27
00860010987926HypoPan10092025-06-17
00860013471606HypoFoam10002025-06-17
00855204008006TPAKTM-303TM-3032019-10-03
00855204008013TVACTM-909TM-9092019-10-03
00855204008020Ptensys Bleeding Control StationTM-400TM-4002019-10-03
00855204008037Ptensys Bleeding Control KitsTM-401TM-4012019-10-03
00855204008051TPAKTM-310TM-3102019-10-03
00855204008068TYTEK TRAUMA BANDAGETM-204TM-2042019-10-03
00855204008075TYTEK TRAUMA BANDAGETM-206TM-2062019-10-03
00855204008082TYTEK TRAUMA BANDAGETM-212TM-2122019-10-03
00855204008099EZ GAUZETM-215TM-2152019-10-03

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