Primary Device ID | 04049539105561 |
NIH Device Record Key | 20a620e5-2dfa-4200-a625-ffc6d5c8a728 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INTRABEAM SMART Spherical Applicator (40mm) |
Version Model Number | 309120-9040-000 |
Company DUNS | 342228620 |
Company Name | Carl Zeiss Meditec AG |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04049539105561 [Primary] |
JAD | System, Therapeutic, X-Ray |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-22 |
Device Publish Date | 2025-05-14 |
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04049539105523 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
04049539105530 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm) | 2025-05-22 |
04049539105554 - INTRABEAM SMART Spherical Applicator (35mm) | 2025-05-22 |
04049539105561 - INTRABEAM SMART Spherical Applicator (40mm) | 2025-05-22 |
04049539105561 - INTRABEAM SMART Spherical Applicator (40mm) | 2025-05-22 |
04049539105578 - INTRABEAM SMART Spherical Applicator (45mm) | 2025-05-22 |
04049539064080 - INTRABEAM | 2025-04-09 The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be pla |