FDA.report

SeaDragon2™

Primary DI
10884450458065
Brand
SeaDragon2™
Company
Merit Medical Systems, Inc.
Model
00884450458068
Catalog number
TD500/A
Published
2020-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQXWire, guide, catheter
PTLWire, Guide, Catheter, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
PTLWire, Guide, Catheter, ExemptCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450458065PackageGS110In Commercial Distribution
20884450458062PackageGS114In Commercial Distribution
00884450458068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445045806510884450458065
2088445045806220884450458062
00884450458068008844504580688844504580680884450458068

GMDN Terms

TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
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 DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10816349013536GuideRightLake Region MedicalDQX2026-03-24
10816349013543GuideRightLake Region MedicalDQX2026-03-24
10816349013550GuideRightLake Region MedicalDQX2026-03-24
10816349013567GuideRightLake Region MedicalDQX2026-03-24
10816349013574GuideRightLake Region MedicalDQX2026-03-24
10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
10816349013604GuideRightLake Region MedicalDQX2026-03-24
10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
16936733736408ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736415ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736644ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736651ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736668ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
06936733736678ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736965ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736996ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737009ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737085ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27