| Primary Device ID | 00849771041313 |
| NIH Device Record Key | a2044544-5dbc-44bb-a851-97f3d84d37c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Key Surgical Endoscope Valves |
| Version Model Number | EN10229PB |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 1 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771041306 [Primary] |
| GS1 | 00849771041313 [Package] Contains: 00849771041306 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 10849771041310 [Package] Contains: 00849771041306 Package: Case [4 Units] In Commercial Distribution |
| OCX | Endoscopic Irrigation/Suction System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-13 |
| Device Publish Date | 2021-04-05 |
| 00849771047643 - NA | 2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch |
| 00849771048077 - NA | 2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium |
| 00849771048220 - NA | 2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long |
| 00849771048244 - NA | 2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long |
| 10849771050473 - NA | 2024-04-01 Suture Booties, White, Sterile, 5 pair per pad |
| 00849771051275 - NA | 2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing |
| 00849771051534 - Key Surgical Endoscope Brushes | 2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead |
| 00849771051619 - Key Surgical Endoscope Brushes | 2024-04-01 Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered diameter |