| Primary Device ID | 10810006683834 |
| NIH Device Record Key | c5c326d1-3164-4b86-a037-2588da7823e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glide & Guide Turn System Kit Economy |
| Version Model Number | GGTS03B |
| Catalog Number | GGTS03B |
| 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 | false |
| 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 | 00810006683837 [Primary] |
| GS1 | 10810006683834 [Package] Contains: 00810006683837 Package: Kit [12 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 | 2021-08-03 |
| Device Publish Date | 2021-07-26 |
| 10810006684107 | GGTS04B Glide & Guide Turn System Kit Economy Includes: 1 each - GGE5660 and 1 set - BPW11R; 10 |
| 10810006684091 | GGTS04 Glide & Guide Turn System Kit Economy Includes: 1 each - GGE3660 and 1 set - BPW11R; 10 K |
| 10810006683834 | GGTS03B Glide & Guide Turn System Kit Economy Includes: 1 each - GGE5660 and 1 set - BPW10F; 12 |
| 10810006683827 | GGTS03 Glide & Guide Turn System Kit Economy Includes: 1 each - GGE3660 and 1 set - BPW10F; 12 K |