| Primary Device ID | 50849771050556 |
| NIH Device Record Key | 22aaadb7-d41b-4df8-8321-6a83414de40b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | K-Wire and Pin Covers |
| Catalog Number | C035 |
| 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 |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 0.035 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771004196 [Previous] |
| GS1 | 00849771050551 [Unit of Use] |
| GS1 | 10849771050558 [Primary] |
| GS1 | 50849771050556 [Package] Contains: 10849771050558 Package: Box [12 Units] In Commercial Distribution |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
| 00849771048169 - NA | 2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long |
| 00849771049012 - NA | 2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long |
| 00849771049128 - NA | 2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long |
| 60849771050416 - Electro Lube | 2025-05-02 Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. |
| 00849771046356 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 20 |
| 00849771046363 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22 |
| 00849771046370 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24 |
| 00849771046387 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25 |