| Primary Device ID | 00849771047315 | 
| NIH Device Record Key | 4625dca3-008f-4758-8adc-906cdae1f6a8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | WR200-30-30 | 
| Catalog Number | WR2003030 | 
| Company DUNS | 604056226 | 
| Company Name | KEY SURGICAL, INC. | 
| Device Count | 144 | 
| DM Exempt | false | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Length | 22 Inch | 
| Width | 18 Inch | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00849771047315 [Unit of Use] | 
| GS1 | 10849771047312 [Primary] | 
| FRG | Wrap, sterilization | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-05-02 | 
| Device Publish Date | 2022-04-22 | 
| 00849771052159 - NA | 2025-08-27 Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long | 
| 00849771048237 - NA | 2025-08-19 K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long | 
| 00849771049036 - NA | 2025-08-19 K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long | 
| 00849771049289 - NA | 2025-08-19 K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long | 
| 00849771049500 - NA | 2025-08-19 K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch | 
| 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 |