NovaSure NS2013US
GUDID 15420045501119
Hologic, Inc.
Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal| Primary Device ID | 15420045501119 |
| NIH Device Record Key | 4f4976c9-121a-4be7-a517-e2675237f439 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaSure |
| Version Model Number | 2013 |
| Catalog Number | NS2013US |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045501119 [Primary] |
| GS1 | 25420045501116 [Package] Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 35420045501113 [Package] Contains: 25420045501116 Package: CARTON [3 Units] In Commercial Distribution |
| GS1 | 45420045501110 [Package] Contains: 35420045501113 Package: BOX [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010013
FDA Product Code
| MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[15420045501119]
Ethylene Oxide
[15420045501119]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-16 |
On-Brand Devices [NovaSure]
| 15420045501140 | 2000 |
| 15420045501119 | 2013 |
| 15420045500860 | NovaSure Controller |
| 15420045500853 | NovaSure Controller |
| 25420045514307 | V5 |
| 15420045514300 | V5 |
| 15420045514294 | V5 |
| 15420045515154 | V5 |
Trademark Results [NovaSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVASURE 90566013 not registered Live/Pending |
Hologic, Inc. 2021-03-08 |
 NOVASURE 75569943 2513050 Live/Registered |
CYTYC CORPORATION 1998-10-14 |
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