FDA.reportPublic FDA data

Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle

Primary DI
00842102106354
Brand
Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle
Company
FLEXBAR MACHINE CORPORATION
Model
D1004
Catalog number
D1004
Device description
Cholangiography Catheter - Percutaneous Flexible
Published
2017-03-24
Public version status
Update
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
GBZCatheter, Cholangiography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842102106351PackageGS110In Commercial Distribution
00842102106354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084210210635110842102106351
00842102106354008421021063548421021063540842102106354

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
047644935
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

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00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
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00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810158211889PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
00733132657902GORE TIPS SetW. L. Gore & Associates, Inc.GBZ2024-07-15
14026704924353TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924360TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
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14026704924421TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924438TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
G587MAS0070PRINCETONPrinceton Medical Group, Inc.GBZ2023-12-14
04049197181631Guyon Catheters RZ-Medizintechnik GmbHGBZ2023-08-16
04049197264310Metal CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197264440Metal catheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466059FOLEY CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466080Rotunda KatheterRZ-Medizintechnik GmbHGBZ2023-08-16
B80291000american catheter CORPAmerican Catheter Corp.GBZ2023-06-20
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