FDA.reportPublic FDA data

Puncture needle

Primary DI
06971162818076
Brand
Puncture needle
Company
Tianck Medical Co., Ltd.
Model
18G
Catalog number
271001
Published
2023-05-17
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971162818073PackageGS1150In Commercial Distribution
26971162818070PackageGS110In Commercial Distribution
06971162818076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697116281807316971162818073
2697116281807026971162818070
06971162818076069711628180766971162818076

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sterile, 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. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418642903
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936841212620Balloon Inflation DeviceBT-30 (30mL) -DG2025-11-12
06936841236329Balloon Inflation DeviceBT-30 (25mL) -DG1000022025-11-12
06971162817789Balloon inflation deviceGTHV1020032024-08-02
06936841208326Connecting Tube1200PSI 3.81*60CM0430132023-02-07
06936841201976Balloon inflation deviceATHV1030032023-05-18
06936841208128Connecting Tube500PSI 3.05*150CM0420102023-05-18
16936841201973Balloon inflation deviceATHV1030032023-05-18
16936841208125Connecting Tube500PSI 3.05*150CM0420102023-05-18
06971162811817Closed suction catheter12F2210042023-02-06
06936841208098IV cannula II-B-18G1750052023-02-06
06936841209187Suction tube12F2210042023-02-06
06971162810971Radial artery closure bandTB-011910012023-02-06
06971162812081ManifoldM-021210022023-02-06
06971162812098ManifoldM-031210032023-02-06
06971162819707Balloon inflation deviceAT25ML1030022023-02-06
06971162819738Balloon inflation deviceBT25ML1040022023-02-06
06936841200092Radial artery closure bandTB-03S1910052023-03-21
06936841200122Radial artery closure bandTB-03M1910042023-03-21
06936841201037Balloon inflation deviceBT401040042023-02-06
06971162817437Balloon inflation deviceGT20ML1020012023-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135391Redemption VILEX LLCDRC2026-01-12
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28
00858769006241Transseptal NeedlePPMDMDRC2018-11-28
00858769006258Transseptal NeedlePPMDMDRC2018-11-28
10884450151850Merit Advance®Merit Medical Systems, Inc.DRC2018-06-11
00858769006104SafeSept Transseptal GuidwirePPMDMDRC2018-03-02