What is FDA product code OAJ?

To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones

General & Plastic Surgery › SurgicalCatheter, Drainage, Intraoral/Extraoral

Sialocath Salivary Duct Catheter

Name: Sialocath Salivary Duct Catheter
Brand: Sialocath Salivary Duct Catheter

Catalogue number SDC-2.2-20, listed by C2Dx, Inc., United States, under Catheter, Drainage, Intraoral/Extraoral. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shandong (2), Zhejiang (1).

Chinese manufacturers registered for FDA product code OAJ
Manufacturer	City	Province	Registered as	Device types
Hynaut Health Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	68
Shandong Zhushi Pharmaceutical Group Co., Ltd.	Heze	Shandong	Contract manufacturer	65
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44

Record

Regulatory record for Sialocath Salivary Duct Catheter
Listed by	C2Dx, Inc., United States
FDA product code	OAJ
Device type	Catheter, Drainage, Intraoral/Extraoral
Device class	Class 1
Regulation	21 CFR 878.4200
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2026-02-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Sialocath Salivary Duct Catheter
Catalogue number	Size	Status
SDC-2.2-20		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Rabinov	Cook Incorporated	8
Manashil	Cook Incorporated	4
Kolenda	Cook Incorporated	2
Yune-Klatte	Cook Incorporated	2
SialoCath	Cook Incorporated	1
Kolenda Salivary Introducer Set – 6.0	C2Dx, Inc.	1
Kolenda Salivary Introducer Set – 5.0	C2Dx, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.