FDA.reportPublic FDA data

NAVICROSS

Primary DI
54987350709184
Brand
NAVICROSS
Company
TERUMO CORPORATION
Model
NC35901
Catalog number
WS*NA35093H
Device description
NAVICROSS Support 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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350709184PackageGS15In Commercial Distribution
04987350709189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070918454987350709184
04987350709189049873507091894987350709189

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length90Centimeter
Outer Diameter1.39Millimeter
Pressure5171KiloPascal

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350740601GLIDEWIRE GT-RGT*GW1618AGT*GW1618A2026-02-06
04987350740625GLIDEWIRE GT-RGT*GA1818AGT*GA1818A2026-02-06
04987350740649GLIDEWIRE GT-RGT*GA1822AGT*GA1822A2026-02-06
54987350740668GLIDEWIRE GT-RGT*GE1818AGT*GE1818A2026-02-06
04987350740687GLIDEWIRE GT-RGT*GE1822AGT*GE1822A2026-02-06
54987350740699GLIDEWIRE GT-RGT*GW1818AGT*GW1818A2026-02-06
04987350740700GLIDEWIRE GT-RGT*GW1822AGT*GW1822A2026-02-06
04987350745422GLIDEWIRE GT-RGT*GW1622AGT*GW1622A2026-02-06
04987350744487DUALVIEWTU-DSS01CTU*DV01U2026-01-21
54953170465050VISIGLIDEG-240-2527AN36222312025-07-14
54953170465067VISIGLIDEG-240-2545AN36224312025-07-14
54953170465074VISIGLIDEG-240-3527AN36226312025-07-14
54953170465081VISIGLIDEG-240-3545AN36228312025-07-14
54953170465098VISIGLIDEG-240-2527SN36221312025-07-14
54953170465104VISIGLIDEG-240-2545SN36223312025-07-14
54953170465111VISIGLIDEG-240-3527SN36225312025-07-14
54953170465128VISIGLIDEG-240-3545SN36227312025-07-14
54953170465135VISIGLIDE2G-260-2527AN53677312025-07-14
54953170465142VISIGLIDE2G-260-2545AN53681312025-07-14
54953170465159VISIGLIDE2G-260-3527AN53679312025-07-14

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Primary DI, Brand, Company table
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