FDA.report

Misago®

Primary DI
54987350722282
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

Related Records

Contact Domains

Product Codes

CodeName
NIPStent, Superficial Femoral Artery

Product Code Classifications

CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54987350722282PackageGS15In Commercial Distribution
04987350722287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5498735072228254987350722282
04987350722287049873507222874987350722287

GMDN Terms

TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length40Millimeter
Lumen/Inner Diameter8Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Stacking limit by 10

Sterilization Methods

Method

Contacts

PhoneEmail
18002837866tmccustomer.admin@terumomedica
+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

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