| Primary Device ID | 00810117210670 | 
| NIH Device Record Key | a4ae89e0-e17f-470b-9c3a-21694032f896 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Eckert & Ziegler Isotope Products, Inc. | 
| Version Model Number | A3533-4 | 
| Company DUNS | 041668633 | 
| Company Name | Eckert & Ziegler Isotope Products, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810117210670 [Primary] | 
| IYQ | Phantom, Flood Source, Nuclear | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-15 | 
| Device Publish Date | 2022-12-07 | 
| 00810117211301 | Attenuation Correction Line Source | 
| 00810117211295 | Attenuation Correction Line Source | 
| 00810117211288 | Attenuation Correction Line Source | 
| 00810117211271 | Attenuation Correction Line Source | 
| 00810117211264 | Attenuation Correction Line Source | 
| 00810117211257 | Attenuation Correction Line Source | 
| 00810117211240 | Attenuation Correction Line Source | 
| 00810117211233 | Attenuation Correction Line Source | 
| 00810117211226 | Attenuation Correction Line Source | 
| 00810117211219 | Attenuation Correction Line Source | 
| 00810117211202 | Attenuation Correction Line Source | 
| 00810117211196 | Attenuation Correction Line Source | 
| 00810117211189 | Attenuation Correction Line Source | 
| 00810117211172 | Attenuation Correction Line Source | 
| 00810117211165 | Attenuation Correction Line Source | 
| 00810117211158 | Attenuation Correction Line Source | 
| 00810117211141 | Attenuation Correction Point Source | 
| 00810117211134 | Attenuation Correction Point Source | 
| 00810117211127 | Attenuation Correction Point Source | 
| 00810117211110 | Attenuation Correction Point Source | 
| 00810117211103 | Dose Calibrator Vial 10mL | 
| 00810117211097 | Dose Calibrator Vial 20mL | 
| 00810117211080 | Gd-153 Breast Biopsy Source | 
| 00810117211073 | HEGL-0143 PET Marker Source | 
| 00810117211066 | Ce-139 Biopsy Source | 
| 00810117211059 | Penpoint Source | 
| 00810117211042 | Flexible Marker Source | 
| 00810117211035 | Flexible Ruler Source | 
| 00810117211028 | Rigid Ruler Source | 
| 00810117211011 | MED3505 Left Marker Source | 
| 00810117211004 | MED3505 Right Marker Source | 
| 00810117210991 | MMS16 Multimodality Marker Source | 
| 00810117210984 | MMS10 Multimodality Marker Source | 
| 00810117210977 | MMS07 Multimodality Marker Source | 
| 00810117210960 | Intramedical Spot Marker Source | 
| 00810117210953 | MMS06 Multimodality Marker Source | 
| 00810117210946 | MMS03 Multimodality Marker Source | 
| 00810117210939 | MMS02 Multimodality Marker Source | 
| 00810117210922 | MMS05 Multimodality Marker Source | 
| 00810117210915 | MMS01 Multimodality Marker Source | 
| 00810117210908 | Spot Marker Source | 
| 00810117210892 | CAL 2600(N) Source | 
| 00810117210885 | CAL 2600 Source | 
| 00810117210878 | Type T2 Medical Check Standards Source | 
| 00810117210861 | Type T1 Medical Check Standards Source | 
| 00810117210854 | Type R3 Medical Check Standards Source | 
| 00810117210847 | Type R5 Medical Check Standards Source | 
| 00810117210830 | Type R5 Medical Check Standards Source | 
| 00810117210823 | Type D Medical Check Standards Source | 
| 00810117210816 | Type D Medical Check Standards Source |