| Primary Device ID | 00385640000109 |
| NIH Device Record Key | 25c57451-4dc7-4bdf-8b6c-3b6ff25d6f32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Sheeting |
| Version Model Number | SP-65000 |
| Catalog Number | SP-65000 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640000109 [Primary] |
| GS1 | 10385640000106 [Package] Package: SHELF BOX [10 Units] In Commercial Distribution |
| MDA | Elastomer, Silicone, For Scar Management |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-20 |
| Device Publish Date | 2016-08-09 |
| 00385640033367 | SP-66150 |
| 00385640033350 | SP-66100 |
| 00385640033343 | SP-66050 |
| 00385640033336 | SP-66025 |
| 00385640033329 | SP-66012 |
| 00385640000116 | SP-65100 |
| 00385640000109 | SP-65000 |