| Primary Device ID | 10311960619483 |
| NIH Device Record Key | fbd24bf0-1c6a-4de7-b45b-8aec6eef5d60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cramer Orthogel |
| Version Model Number | 061925 |
| Company DUNS | 007138183 |
| Company Name | CRAMER PRODUCTS, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| 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 | true |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00311960619486 [Primary] |
| GS1 | 10311960619483 [Package] Contains: 00311960619486 Package: Master [9 Units] In Commercial Distribution |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-16 |
| Device Publish Date | 2019-04-08 |
| 10311960620724 | Cramer Orthogel, Two 3/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biolog |
| 10311960620717 | Cramer Orthogel, Two 1/4" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biolog |
| 10311960620700 | Cramer Orthogel, Two 1/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biolog |
| 10311960619483 | Cramer Orthogel Kit - One 12" x 12" sheet of 1/8", 1/4" and 3/8" thick sheets |