FDA.reportPublic FDA data

Cardiovascular Procedure Kit

Primary DI
00699753532182
Brand
Cardiovascular Procedure Kit
Company
Terumo Cardiovascular Systems Corporation
Model
CX-FR462
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753532187PackageGS14In Commercial Distribution
00699753532182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975353218750699753532187
00699753532182006997535321826997535321820699753532182

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753537880Cardiovascular Procedure Kit788312026-08-26
00699753537897Cardiovascular Procedure Kit788332026-08-26
00699753537903Cardiovascular Procedure KitCX-CZ226X2026-08-26
00699753537910Cardiovascular Procedure KitCX-UK7672026-08-26
00699753537927Cardiovascular Procedure KitCX-UK7682026-08-26
00699753537934Cardiovascular Procedure KitCX-UK7692026-08-26
00699753537941Cardiovascular Procedure KitCX-UK770X2026-08-26
00699753537958Cardiovascular Procedure KitCX-UK7712026-08-26
00699753537866Cardiovascular Procedure Kit75643-052026-08-21
00699753537873Cardiovascular Procedure Kit787982026-08-21
00699753537811Cardiovascular Procedure KitCX-PL1642026-08-17
00699753537828Cardiovascular Procedure KitCX-PL1652026-08-17
00699753537743Cardiovascular Procedure Kit788052026-08-03
00699753537750Cardiovascular Procedure Kit788122026-08-03
00699753537767Cardiovascular Procedure Kit786712026-08-03
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18