Kolenda Salivary Introducer Set - 6.0

GUDID 00850007350352

C2DX, INC.

Salivary gland catheter
Primary Device ID00850007350352
NIH Device Record Key6ab42cfb-63c5-4129-adc3-321fc913fab6
Commercial Distribution StatusIn Commercial Distribution
Brand NameKolenda Salivary Introducer Set - 6.0
Version Model NumberSDAS-6.0-18
Company DUNS116981210
Company NameC2DX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com
Phone888-902-2239
Emailinfo@everismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007350352 [Primary]

FDA Product Code

OAJCatheter, Drainage, Intraoral/Extraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-18
Device Publish Date2026-02-10

Devices Manufactured by C2DX, INC.

00850007350321 - Wire Guide2026-02-18
00850007350338 - Salivary Access Dilator Set2026-02-18
00850007350345 - Kolenda Salivary Introducer Set - 5.02026-02-18
00850007350352 - Kolenda Salivary Introducer Set - 6.02026-02-18
00850007350352 - Kolenda Salivary Introducer Set - 6.02026-02-18
00850007350369 - NGage Salivary Stone Extractor2026-02-18
00850007350376 - NCircle Tipless Salivary Stone Extractor2026-02-18
00850007350383 - Sialocath Salivary Duct Catheter2026-02-18
00850007350390 - Advance Salivary Duct Balloon Catheter Set - 1.52026-02-18

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