| Primary Device ID | 00810006680850 |
| NIH Device Record Key | 62d289e8-b422-4253-b462-e941aafb8042 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glide & Guide Turn Sheet Select |
| Version Model Number | GGS5660TSF |
| Catalog Number | GGS5660TSF |
| Company DUNS | 958758146 |
| Company Name | PRIMO 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 | 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 | 00810006680461 [Primary] |
| GS1 | 00810006680850 [Package] Contains: 00810006680461 Package: CASE [5 Units] In Commercial Distribution |
| FMR | Device, Transfer, Patient, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-27 |
| 00810006680850 | Select Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Top Straps |
| 00810006680836 | Select Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Side Straps |
| 00810006680812 | Glide & Guide Turn Sheet - Bariatric (56" x 60") |
| 00810006680775 | Glide & Guide Turn Sheet (36" x 60") w/ Top Straps |
| 00810006680751 | Glide & Guide Turn Sheet (36" x 60") w/ Side Straps |
| 00810006680744 | Glide & Guide Turn Sheet (36" x 60") |