Primary Device ID | 04049471100167 |
NIH Device Record Key | df0d8fd4-ff3b-4efc-97d3-39413966a964 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Treatment Pack (Type KP) |
Version Model Number | 1016 |
Company DUNS | 314594680 |
Company Name | Carl Zeiss Meditec AG |
Device Count | 10 |
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 | false |
Manufacturing Date | true |
Expiration Date | true |
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 | 04049471100167 [Unit of Use] |
GS1 | 04049471110166 [Primary] |
HQF | Laser, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-19 |
Device Publish Date | 2024-02-09 |
04049539105516 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
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 |
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 |