FDA.reportPublic FDA data

FINECROSS

Primary DI
04987350703187
Brand
FINECROSS
Company
TERUMO CORPORATION
Model
35-1450
Catalog number
NC*F865A
Device description
FINECROSS MG Coronary Micro-Guide Catheter
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350703182PackageGS15In Commercial Distribution
04987350703187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070318254987350703182
04987350703187049873507031874987350703187

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

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
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09
04987350383099HEARTRAIL40-6371GC-U6IL350A2016-09-09
04987350383112HEARTRAIL40-6372GC-U6IL3G0N2016-09-09
04987350383136HEARTRAIL40-6373GC-U6IL400N2016-09-09
04987350383150HEARTRAIL40-6374GC-U6IL400A2016-09-09
04987350383174HEARTRAIL40-6375GC-U6IL450N2016-09-09
04987350383198HEARTRAIL40-6376GC-U6IL450A2016-09-09
04987350383235HEARTRAIL40-6380GC-U6IR100N2016-09-09
04987350383259HEARTRAIL40-6381GC-U6IR150N2016-09-09
04987350383273HEARTRAIL40-6382GC-U6IR200N2016-09-09
04987350423795HEARTRAIL40-6383GC-U6IR100A2016-09-09
04987350423818HEARTRAIL40-6385GC-U6IR200A2016-09-09
04987350423832HEARTRAIL40-6377GC-U6IL3G0A2016-09-09
04987350423856HEARTRAIL40-6384GC-U6IR150A2016-09-09
04987350423870HEARTRAIL40-6311GC-U6TG400N2016-09-09
04987350703163FINECROSS35-1430NC*F863A2016-09-09
04987350709165NAVICROSSNC35651WS*NA350G3H2016-09-09
04987350709189NAVICROSSNC35901WS*NA35093H2016-09-09
04987350709202NAVICROSSNC35131WS*NA350N3H2016-09-09
04987350709226NAVICROSSNC35151WS*NA35153H2016-09-09

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Primary DI, Brand, Company table
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00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
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