FDA UDI In Commercial Distribution 🇺🇸 United States

MISI-Medical Imaging Solutions International

DI: 00628725095066 · Model: 100101 · Canadian Hospital Specialties Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
MISI-Medical Imaging Solutions International
Primary DI
00628725095066
Version / Model
100101
Catalog Number
100101
Company Name
Canadian Hospital Specialties Limited
Labeler DUNS
240992693
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-08-15
Public Version
1
Public Version Date
2025-08-25
Public Version Status
New
Public Device Record Key
8e35afdd-d981-454d-ad43-8e3858a1f4e6

Device Description

CT Angiographic Syringe 1-200ml Syringe, 1-Large Spike, 1-Fill Straw, 1-60" Coiled tubing

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
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
DXT Injector And Syringe, Angiographic

GMDN Terms

Code Name
15286 Angiographic syringe

Identifiers

Type ID
Primary 00628725095066
Package 50628725095061

Customer Contacts

Phone
9058259300