FDA.reportPublic FDA data

R2P NAVICROSS

Primary DI
50389701012907
Brand
R2P NAVICROSS
Company
TERUMO MEDICAL CORPORATION
Model
SC-R35ANG200
Catalog number
SC-R35ANG200
Device description
R2P NAVICROSS
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231044000R2P NavicrossTerumo Medical Corporation2023-07-27DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50389701012907PackageGS15In Commercial Distribution
00389701012902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038970101290750389701012907
00389701012902003897010129023897010129020389701012902

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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid direct sunlight. Keep dry
Special Storage Condition, Specify00Do not store at extreme temperature and humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131489882
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
00389701006161DESTINATIONRSR01RSR012016-09-24
00389701006178DESTINATIONRSR02RSR022016-09-24
00389701006185DESTINATIONRSR03RSR032016-09-24
00389701006192DESTINATIONRSR04RSR042016-09-24
00389701006208DESTINATIONRSR05RSR052016-09-24
00389701006215DESTINATIONRSR06RSR062016-09-24
00389701006222DESTINATIONRSR07RSR072016-09-24
00389701006239DESTINATIONRSR08RSR082016-09-24
00389701006246DESTINATIONRSR09RSR092016-09-24
00389701006253DESTINATIONRSR10RSR102016-09-24
00389701006260DESTINATIONRSR11RSR112016-09-24
00389701006277DESTINATIONRSR12RSR122016-09-24
00389701006796DESTINATIONRSC01RSC012016-09-24
00389701006802DESTINATIONRSC02RSC022016-09-24
00389701006970DESTINATIONRSR13RSR132016-09-24
00389701006987DESTINATIONRSR15RSR152016-09-24
00389701006994DESTINATIONRSR17RSR172016-09-24
00389701007007DESTINATIONRSR19RSR192016-09-24
00389701007168DESTINATIONRSR14RSR142016-09-24
00389701007175DESTINATIONRSR16RSR162016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
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00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
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00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03