This page includes the latest FDA filings for Nordion Canada Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010131578 | ||||||||||
| FEI Number | 3010131578 | ||||||||||
| Name | Jeff Smith | ||||||||||
| Owner & Operator | Nordion Canada Inc. | ||||||||||
| Contact Address | 447 MARCH RD. -- OTTAWA CA-ON Ontario K2K1X8 CA | ||||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 33 Wood Ave. Ste 637 Iselin, NJ 08830 US | ||||||||||
| Establishment Type | Sterilize Medical Device for Another Party (Contract Sterilizer) |
Device Company | Device | Date |
|---|---|---|
Jeff Smith [Nordion Canada Inc.] | KerraCel Ag Gelling Fiber Dressing | 2017-07-26 |
Jeff Smith [Nordion Canada Inc.] | exsalt T7 Wound Dressing/ KerraContact Ag Wound Dressing | 2017-07-26 |
| NCAGE Code | L0392 | NORDION (CANADA) INC^DBA NORDION |
| CAGE Code | L0392 | NORDION (CANADA) INC NORDION |
| SEC | 0001200045 | NORDION (CANADA) INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019060471344 | Halifax, NS,Canada -> New York/Newark Area, Newark, New Jersey | PIECES 1 CASK 'RQ', UN2916 RADIOACTIVE MATERIAL, TYP B(U) PACKAGE, CLASS 7, RADIOISOTOPE: COBALT 60, SPECIAL FORM, CHEMIC FORM: COBALT METAL/PHYSICAL FORM: SOLID, TOTA ACTIVITY: 3699.9TBQ TOTAL TRANSPORT INDEX: 3.2, CATEGORY RADIOACT | 2 PCS |
| 2019053075586 | Vancouver, BC ,Canada -> Seattle, Washington | TOOL KIT | 1 CRT |
| 2019052760583 | Halifax, NS,Canada -> New York/Newark Area, Newark, New Jersey | 1X20FT OT CONTAINER I TARP REMOVED I CONTAINI NG: 1 CASK: RQ, UN2916, RADIOACTIVE MATERIAL, TYPE B(U) PACKAGE, NON FISSILE, CLASS 7, RAD IOISOTOPE: COBALT 60, SPECIAL FORM, CHEMICAL FORM: COBALT METAL I PHYSICAL FORM: SOLID, TO TAL ACTIVTY: 6659.9TBQ, TOTAL TRANSPORT INDEX : 5.8, CATEGORY RADIOACTIVE III YELLOW, TYPE | 1 CSK |
| 2019052164589 | Halifax, NS,Canada -> New York/Newark Area, Newark, New Jersey | CASKS . RQ, UN2916 RADIOACTIVE MATERIAL, TYPE B(U) PACKAGE, NON FISSILE, CLASS 7, RADIOISOTOPE: COBALT 60, SPECIAL FORM, TOTAL ACTIVITY: 12,949.8TBQ TOTAL TRANSPORT INDEX: 10.1 CATEGORY RADIOACT | 2 PCS |
| 2019051420561 | Port Swettenham,Malaysia -> Seattle, Washington | 1 X 20'OT CONTAINER :- 2 CASES EMPTY RE-USABLE LEAD SHIPPING CONTAINERS FLASK SERIAL NO. : ( F / 168 66, 137 ) CANADIAN GOODS RETURNED HS CODE : 8303 00 0000 TEL : 613-592-3400 EXT 2286 | 2 PCS |
| 2019051324760 | Port Swettenham,Malaysia -> Seattle, Washington | 1 X 20'OT CONTAINER :- 2 CASES EMPTY RE-USABLE LEAD SHIPPING CONTAINERS FLASK SERIAL NO. : ( F / 168 66, 137 ) CANADIAN GOODS RETURNED HS CODE : 8303 00 0000 TEL : 613-592-3400 EXT 2286 | 2 PCS |
| 2019050959425 | Sao Paulo,Brazil -> New York, New York | 'RQ ,UN 2916 RADIOACTIVE MATERIAL, TYPE B(U) PACKAGE, (COBALT 60),1255 TBQ, RADIATION AT SURFACE 80 USV/H, RADIATION AT IM 13 USV/H, TI 1.3, REVISS. SPECIAL FORM CERTIFICATE, IAEA SPECIAL FORM CERTIFICATE NO:GB/343/S-96 (REV. 5) | 3 PKG |
| 2019050732356 | St. Petersburg,Russia -> Philadelphia, Pennsylvania | 20'' FLAT RACK FOLDING ENDS CONTAINERS TYPE F -231 # 12,14WITH GAMMA-RADIATION SOURCES COBA LT-60RQ,UN2916 RADIOACTIVE MATERIAL.TYPE B(U) PACKAGE; NON-FISSILE.CLASS 7, SCHEDULE 10. | 4 PCS |
| 2019050732356 | St. Petersburg,Russia -> Philadelphia, Pennsylvania | 20'' FLAT RACK FOLDING ENDS CONTAINERS TYPE F -231 # 46, 50WITH GAMMA-RADIATION SOURCES COB ALT-60RQ,UN2916 RADIOACTIVE MATERIAL.TYPE B(U ) PACKAGE; NON-FISSILE.CLASS 7, SCHEDULE 10.C OBALT-60 TYPE AC339 IN SPECIAL FORM,SOURCESIN 4 CONTAINERS TYPE F-231 #12,14,46,50CERTIFIC ATE PACKAGE:RUS/7226/B(U)-96T;CDN/2077/B(U)-9 | 4 PCS |