CoreBloc

Basic Information

• Brand Name: CoreBloc
• Primary DI: 07350081910099
• Version / Model: SK820000
• Catalog Number: SK820000
• Company Name: Prostalund AB
• Labeler DUNS: 554703897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-05
• Public Version: 1
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 9bcd5b99-4370-4f4e-b080-8e8fb72cfc4f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45158	Percutaneous medicine administration kit, non-medicated, single-use	A collection of sterile devices intended to be used to administer various types of medication (non-dedicated) by injection. It will typically contain a syringe, a needle, extension tubing, adaptors, and antiseptic applicator, but not the medication. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27350081910093	GS1		10	In Commercial Distribution
Primary	07350081910099	GS1