| Primary Device ID | 15420045512436 |
| NIH Device Record Key | d0dde7fd-a253-47a0-9136-5cda89ae1125 |
| Commercial Distribution Discontinuation | 2024-05-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DEFINITY CERVICAL DILATOR, 9MM |
| Version Model Number | DCD-901 |
| Catalog Number | DCD-901 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045512436 [Primary] |
| PON | Catheter, balloon, dilation of cervical canal |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
[15420045512436]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-07-29 |
| Device Publish Date | 2020-02-05 |
| 35420045512430 | DCD-901 |
| 15420045512436 | DCD-901 |