| Primary Device ID | 16975424191683 |
| NIH Device Record Key | 1f82c71d-272a-4070-8784-b9859ec16566 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Future Generation Medical |
| Version Model Number | FGM-D1847 |
| Catalog Number | FGM-D1847 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975424191686 [Primary] |
| GS1 | 16975424191683 [Package] Contains: 06975424191686 Package: Inner Case [10 Units] In Commercial Distribution |
| GS1 | 26975424191680 [Package] Package: Case [4 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-13 |
| Device Publish Date | 2023-04-05 |
| 16975424192406 | Ophthalmic Drape w/ pouch 48" x 51", adhesive area 4" x 5" |
| 16975424192253 | Medium Drape w. Aperture 31" x 51" |
| 16975424192246 | Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture |
| 16975424192093 | "U-Drape, 48"" x 52"", U-Slot Aperture with Adhesive, Clear Plastic - Sterile" |
| 26975424191697 | Large PE Drape 17" x 23" |
| 16975424191683 | Small Towel Drape w. Adhesive Strip 17" x 11" |