FDA.reportPublic FDA data

Misago®

Primary DI
04987350722287
Brand
Misago®
Company
TERUMO CORPORATION
Model
SXR08040L
Catalog number
SX*FXA0840LN
Device description
MISAGO RX Self-expanding Peripheral Stent
Published
2015-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIPStent, Superficial Femoral Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350722282PackageGS15In Commercial Distribution
04987350722287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735072228254987350722282
04987350722287049873507222874987350722287

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal (e.g., Nitinol alloy mesh structure); it does not include a polymer tube (i.e., not a stent-graft). A disposable delivery device may be packaged with the stent.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0
Lumen/Inner Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
690543319
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
false
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
04987350722089Misago®SXR06060LSX*FXA0660LN2015-05-30
04987350722102Misago®SXR06080LSX*FXA0680LN2015-05-30
04987350722126Misago®SXR06120LSX*FXA06X2LN2015-05-30
04987350722140Misago®SXR06150LSX*FXA06X5LN2015-05-30
04987350722164Misago®SXR07040LSX*FXA0740LN2015-05-30
04987350722188Misago®SXR07060LSX*FXA0760LN2015-05-30
04987350722201Misago®SXR07080LSX*FXA0780LN2015-05-30
04987350722225Misago®SXR07100LSX*FXA07X0LN2015-05-30
04987350722300Misago®SXR08060LSX*FXA0860LN2015-05-30
04987350722324Misago®SXR08080LSX*FXA0880LN2015-05-30
04987350722348Misago®SXR08100LSX*FXA08X0LN2015-05-30
04987350722362Misago®SXR06100LSX*FXA06X0LN2015-05-30
04987350722065Misago®SXR06040LSX*FXA0640LN2015-05-30
04987350722249Misago®SXR07120LSX*FXA07X2LN2015-05-30
04987350722263Misago®SXR07150LSX*FXA07X5LN2015-05-30
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002037960Zilver FlexCOOK IRELAND LTDNIP2025-12-04
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082362S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082379S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082386S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
00733132645725GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645824GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645862GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645923GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16
00733132645961GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646005GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646043GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646081GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
00733132646128GORE VIABAHN Endoprosthesis with HeparinW. L. Gore & Associates, Inc.NIP2019-08-16
08717648225888SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225901SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225925SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225949SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225963SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648225987SUPERAABBOTT VASCULAR INC.NIP2018-04-13
08717648226007SUPERAABBOTT VASCULAR INC.NIP2018-04-13