FDA.reportPublic FDA data

SeaDragon2™

Primary DI
00884450458068
Brand
SeaDragon2™
Company
Merit Medical Systems, Inc.
Model
00884450458068
Catalog number
TD500/A
Published
2020-08-14
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
PTLWire, Guide, Catheter, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTLWire, Guide, Catheter, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450458065PackageGS110In Commercial Distribution
20884450458062PackageGS114In Commercial Distribution
00884450458068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445045806510884450458065
2088445045806220884450458062
00884450458068008844504580688844504580680884450458068

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
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
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
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
36927675513480RADIFOCUSTerumo Medical Products (Hangzhou) Co., Ltd.PTL2022-12-08
00860003987353Speed-Torque®Vascugenix, LLCPTL2022-11-03
00860003987360Speed-Torque®Vascugenix, LLCPTL2022-11-03
10860003987350Speed-Torque®Vascugenix, LLCPTL2022-11-03
10860003987367Speed-Torque®Vascugenix, LLCPTL2022-11-03
06947358544302Sunmed guidewire torque deviceSunny Medical Device (Shenzhen) Co., Ltd.PTL2022-01-04
00860003987315Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987322Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987339Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987346Speed Torque Vascugenix, LLCPTL2021-02-03
10884450458065SeaDragon2™Merit Medical Systems, Inc.PTL2020-08-14
06936733735923AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735930AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735947AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735954AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735961AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735978AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736043AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736050AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736067AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736074AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736081AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736098AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735937AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735951AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735968AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736040AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736064AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736088AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
00884450007792Pin ViseMerit Medical Systems, Inc.PTL2016-09-26