| Primary Device ID | 15420045507937 |
| NIH Device Record Key | b59338aa-6ad5-435d-9913-02af30a8f13a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myosure Manual Tissue Removal Device |
| Version Model Number | 20-401ML |
| Catalog Number | 20-401ML |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045507937 [Primary] |
| GS1 | 25420045507934 [Package] Package: CARTON [1 Units] In Commercial Distribution |
| GS1 | 35420045507931 [Package] Contains: 25420045507934 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 45420045507938 [Package] Contains: 25420045507934 Package: BOX [3 Units] In Commercial Distribution |
| HIH | HYSTEROSCOPE (AND ACCESSORIES) |
| NWW | Hysteroscope accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[15420045507937]
Ethylene Oxide
[15420045507937]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-08 |
| 15420045517394 - Hologic | 2025-09-05 NG Res Primers Analyte Specific Reagent. |
| 15420045517400 - Hologic | 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent. |
| 15420045517417 - Hologic | 2025-09-05 NG Res C272T IVT Control (Positive Control). |
| 15420045517424 - Hologic | 2025-09-05 NG IVT Wild Type Control (Negative Control). |
| 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM | 2025-07-29 |
| 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM | 2025-07-29 |
| 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM | 2025-07-29 |
| 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM | 2025-07-25 Computer to operate the Genius™ Review Station. |