| Primary Device ID | 10849771030932 |
| NIH Device Record Key | 3160075e-51cf-42f3-a934-d6cb69fb1fc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Key Surgical Vascular Loops |
| Version Model Number | VL-218 |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 2 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771030935 [Primary] |
| GS1 | 00849771043553 [Unit of Use] |
| GS1 | 10849771030932 [Package] Contains: 00849771030935 Package: Box [10 Units] In Commercial Distribution |
| KDC | Instrument, Surgical, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-17 |
| Device Publish Date | 2020-12-09 |
| 10849771030833 | Vascular Loops, Sterile, Red, Mini, 18" long, 2/pkg |
| 10849771030932 | Vascular Loops, Sterile, White, Super Maxi, 22" long, 2/pkg |
| 10849771030925 | Vascular Loops, Sterile, Red, Maxi, 30" long, 2/pkg |
| 10849771030918 | Vascular Loops, Sterile, Blue, Super Maxi, 18" long, 2/pkg |
| 10849771030901 | Vascular Loops, Sterile, White, Maxi, 18" long, 2/pkg |
| 10849771030895 | Vascular Loops, Sterile, Yellow, Maxi, 18" long, 2/pkg |
| 10849771030888 | Vascular Loops, Sterile, Blue, Maxi, 18" long, 2/pkg |
| 00849771030874 | Vascular Loops, Sterile, Red, Maxi, 18" long, 2/pkg |
| 10849771030864 | Vascular Loops, Sterile, White, Mini, 18" long, 2/pkg |
| 00849771030850 | Vascular Loops, Sterile, Yellow, Mini, 18" long, 2/pkg |
| 10849771030840 | Vascular Loops, Sterile, Blue, Mini, 18" long, 2/pkg |