| Primary Device ID | 35420045512416 |
| NIH Device Record Key | f91bd609-8472-4f5f-a606-95a0b06f941d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEFINITY CERVICAL DILATOR, 5MM |
| Version Model Number | DCD-501 |
| Catalog Number | DCD-501 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045512412 [Primary] |
| GS1 | 25420045512419 [Package] Contains: 15420045512412 Package: BOX [5 Units] In Commercial Distribution |
| GS1 | 25420045512440 [Package] Contains: 15420045512412 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 35420045512416 [Package] Contains: 25420045512419 Package: BOX [5 Units] In Commercial Distribution |
| GS1 | 35420045512447 [Package] Contains: 25420045512440 Package: BOX [1 Units] In Commercial Distribution |
| PON | Catheter, balloon, dilation of cervical canal |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[35420045512416]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-13 |
| Device Publish Date | 2020-02-05 |
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