ProSeal CSTD

Basic Information

• Brand Name: ProSeal CSTD
• Primary DI: 18859299124121
• Version / Model: 421010VT
• Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
• Labeler DUNS: 662213220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-11
• Public Version: 2
• Public Version Date: 2025-09-29
• Public Version Status: Update
• Public Device Record Key: 6e27c84b-a37b-4312-b169-50ed3355c30c

Device Description

ProSeal Injector (DMA Compatible)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60538	Luer/Luer linear connector, single-use	A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38859299124125	GS1	Carton	200	In Commercial Distribution
Primary	18859299124121	GS1

Premarket Submissions

Submission Number	Supplement Number
K192075	000