ImaJin

Basic Information

• Brand Name: ImaJin
• Primary DI: 05708932057479
• Version / Model: AJ4765
• Catalog Number: AJ4765
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-18
• Public Version: 2
• Public Version Date: 2023-09-14
• Public Version Status: Update
• Public Device Record Key: 2fbb52b5-650f-4a8a-bc35-e5829d84ca8d

Device Description

ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 28 cm, Catheter Gauge 6 FR/CH.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FAD	Stent, ureteral	Gastroenterology, Urology	876.4620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60755	Urological surgical procedure kit, non-medicated, single-use	A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932057486	GS1	Retail Box	1	In Commercial Distribution
Primary	05708932057479	GS1
Package	05708932057493	GS1	Shipper Box	34	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	28	Centimeter
Catheter Gauge	6	French