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

FDA UDI

Class I (US FDA UDI)

by Flexbar Machine Corp.

Identity

Trade Name: Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle FDA UDI
Generic Name: Non-vascular catheter introduction set FDA UDI
Device Name: Cholangiography Catheter - Percutaneous Flexible FDA UDI
Model / Reference: D1004 FDA UDI
Description: Cholangiography Catheter - Percutaneous Flexible FDA UDI

Identifiers

Catalog Number: D1004 FDA UDI
Primary DI / UDI-DI: 00842102106354 FDA UDI
FDA Product Code: GBZ FDA UDI
GMDN Term: Non-vascular catheter introduction set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Non-vascular catheter introduction set Rigid endoscopic cannula, single-use

Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle by Flexbar Machine Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Rigid endoscopic cannula, single-use.

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LAP CHOLANGIOGRAPHY CATHETER — RANFAC CORP. · Class I
OPER CHOLANGIOGRAPHY CATHETER — RANFAC CORP. · Class I
CLEAR-TRAC — Smith & Nephew, Inc. · Class I
ORC-A, F/G ASSY, RANFAC, 18 GA — RANFAC CORP. · Class I
INTELIJET — Smith & Nephew, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Flexbar Machine Corp.

Sources (1)

FDA UDI 6585e445-ec22-48ad-82f8-1a59815045da 34 fields · synced May 31, 2026