R2P MISAGO SX*FMA0860RN

GUDID 54987350727669

MISAGO RX Self-expanding Peripheral Stent

TERUMO CORPORATION

Multiple peripheral artery stent, bare-metal
Primary Device ID54987350727669
NIH Device Record Keyfa164262-792f-4e0d-8bce-98f1efab302a
Commercial Distribution StatusIn Commercial Distribution
Brand NameR2P MISAGO
Version Model NumberSXR08060R
Catalog NumberSX*FMA0860RN
Company DUNS690543319
Company NameTERUMO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length60 Millimeter
Lumen/Inner Diameter8 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.

Device Identifiers

Device Issuing AgencyDevice ID
GS104987350727664 [Primary]
GS154987350727669 [Package]
Contains: 04987350727664
Package: Carton [5 Units]
In Commercial Distribution

FDA Product Code

NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2019-08-21

On-Brand Devices [R2P MISAGO]

54987350727782MISAGO RX Self-expanding Peripheral Stent
54987350727768MISAGO RX Self-expanding Peripheral Stent
54987350727744MISAGO RX Self-expanding Peripheral Stent
54987350727720MISAGO RX Self-expanding Peripheral Stent
54987350727706MISAGO RX Self-expanding Peripheral Stent
54987350727683MISAGO RX Self-expanding Peripheral Stent
54987350727669MISAGO RX Self-expanding Peripheral Stent
54987350727645MISAGO RX Self-expanding Peripheral Stent
54987350727621MISAGO RX Self-expanding Peripheral Stent
54987350727607MISAGO RX Self-expanding Peripheral Stent
54987350727584MISAGO RX Self-expanding Peripheral Stent
54987350727560MISAGO RX Self-expanding Peripheral Stent
54987350727546MISAGO RX Self-expanding Peripheral Stent
54987350727522MISAGO RX Self-expanding Peripheral Stent
54987350727508MISAGO RX Self-expanding Peripheral Stent
54987350727485MISAGO RX Self-expanding Peripheral Stent

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.