FDA.report

2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER

Primary DI
30884908093729
Brand
2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER
Company
Medical Components, Inc.
Model
MR190300
Catalog number
MR190300
Device description
3F (1.0MM ID) X 5CM TEARAWAY INTRODUCER SET W/NITINOL GUIDEWIRE W/RADIOPAQUE TIP
Published
2018-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30884908093729PackageGS110Not in Commercial Distribution
50884908093723PackageGS14Not in Commercial Distribution
00884908093728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3088490809372930884908093729
5088490809372350884908093723
00884908093728008849080937288849080937280884908093728

GMDN Terms

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

Contacts

PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags

DUNS number
038000253
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

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20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
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00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
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20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
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20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13
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