| Primary Device ID | 00180668000205 |
| NIH Device Record Key | ebaa8286-d137-4ebb-b211-044524ae4b17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProACT - Tissue Expanding Device II |
| Version Model Number | 750044 |
| Company DUNS | 080378479 |
| Company Name | UROMEDICA INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00180668000205 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00180668000205]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2016-07-15 |
| 00180668000144 - ProACT - Replacement Actuator - Tissue Expanding Device II | 2019-10-31 |
| 00180668000106 - ProACT - Implantation Instrument Set | 2019-01-23 |
| 00180668000137 - ProACT - Blunt Trocar | 2019-01-23 |
| 00180668000205 - ProACT - Tissue Expanding Device II | 2019-01-23 |
| 00180668000205 - ProACT - Tissue Expanding Device II | 2019-01-23 |
| 00180668000236 - ProACT Adjustable Continence Therapy for Men – 12 cm Implants - Patient Pack | 2019-01-23 |
| 00180668000380 - ProACT Adjustable Continence Therapy for Men – 14 cm Implants - Patient Pack | 2019-01-23 |
| 00180668000397 - ProACT Adjustable Continence Therapy for Men – 12 cm Single Implant - Revision | 2019-01-23 |
| 00180668000403 - ProACT Adjustable Continence Therapy for Men – 14 cm Single Implant - Revision | 2019-01-23 |