FDA.reportPublic FDA data

Aspirating Needle 335 x 3.5mm (18g) with Luer

Primary DI
05060212050021
Brand
Aspirating Needle 335 x 3.5mm (18g) with Luer
Company
DTR MEDICAL LIMITED
Model
ASN2018
Published
2026-06-10
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

Product Codes#

Code, Name table
CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060212055422PackageGS120In Commercial Distribution
05060212050021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060212055422050602120554225060212055422
05060212050021050602120500215060212050021

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry / Keep out of Sunlight

Regulatory Flags#

DUNS number
424066509
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
05060212050687Bruenings Tongue Depressor, 190mmBRU20012026-06-10
05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10
05060212051738Clamp Cover White (Med) 120mmCCW20412026-06-10
05060212051745Clamp Cover Blue (Large) 120mmCCB20512026-06-10
05060212052094Tischler Cervical Biopsy PunchCBT10012026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchCBT1001B2026-06-10
05060212052339Cusco Specula Metal SmallCMM200S2026-06-10
05060212052346Cusco Specula Metal MediumCMM200M2026-06-10
05060212052360Cusco Specula Metal LargeCMM200L2026-06-10
05060212052629Cawthorne Hook 1.5mm 90 degree blackCTH2901-D2026-06-10
05060212052636Cawthorne Straight Point blackCTP2001-D2026-06-10
05060212053466Barron Suction Handle (3Fg)BSH20032026-06-10
05060212053473Barron Suction Handle (4Fg)BSH20042026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060212054661Silicone Tube 1.02mm ID x 2.16mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054678Silicone Tube 1.02mm ID x 2.16mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054685Silicone Tube 1.57mm ID x 3.18mm OD x 250mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054692Silicone Tube 1.57mm ID x 3.18mm OD x 250mm long, two piecesDTR MEDICAL LIMITEDBYY2026-06-10
05060212054715Silicone Tube 1.57mm ID x 3.18mm OD x 450mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054722Silicone Tube 1.57mm ID x 3.18mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054753Silicone Tube 1.98mm ID x 3.18mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054791Silicone Tube 2.65mm ID x 4.88mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054814Silicone Tube 3.2mm ID x 6.4mm OD x 200mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054838Silicone Tube 3.2mm ID x 6.4mm OD x 800mm longDTR MEDICAL LIMITEDBYY2026-06-10
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05060212054876Silicone Tube 4.8mm ID x 7.9mm OD x 150mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054883Silicone Tube 4.8mm ID x 7.9mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054890Silicone Tube 4.8mm ID x 7.9mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054913Silicone Tube 4.8mm ID x 7.9mm OD x 760mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054944Silicone Tube 4.8mm ID x 7.9mm OD x 1350mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054951Silicone Tube 4.8mm ID x 7.9mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212054968Silicone Tube 4.8mm ID x 7.9mm OD x 1750mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055002Silicone Tube 5.0mm ID x 8.3mm OD x 600mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055026Silicone Tube 5.0mm ID x 8.3mm OD x 1500mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055095Silicone Tube 6.4mm ID x 9.5mm OD x 300mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055118Silicone Tube 6.4mm ID x 9.5mm OD x 700mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060212055125Silicone Tube 6.4mm ID x 9.5mm OD x 1000mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411983229Sterile Silicone Tube 1.57 ID x 2.41 OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
05060411984066Silicone Tube 3.2mm ID x 6.4mm OD x 400mm longDTR MEDICAL LIMITEDBYY2026-06-10
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