| Primary Device ID | M595S2500 |
| NIH Device Record Key | c3f87df3-159d-4bd2-bf32-56ed32b7bf24 |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Retrieve™ |
| Version Model Number | S250 |
| Catalog Number | S250 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, 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 | 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 | 6312491134 |
| customerservice@parkell.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store this product in a cool, dry place. Refrigeration will prolong shelf life, but avoid freezing. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M595S2500 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2016-09-23 |
| M595S2500 | Retrieve™ Non-Eugenol Resin-Based Implant Cement |
| 00810000525324 | Retrieve™ DC Non-Eugenol Resin-Based Implant Cement |
| 00810000525621 | Retrieve™ DC Non-Eugenol Resin-Based Implant Cement (Korea) |
| 10810000526854 | Mixing Tip with Brown Base for E.T.C.™ & Retrieve™ (Pkg. of 30 pcs.) |