| Primary Device ID | M97024000502006 |
| NIH Device Record Key | dcaa5b7e-6a20-4681-9361-a21ba0bec08e |
| Commercial Distribution Discontinuation | 2023-06-26 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Helical Ridge |
| Version Model Number | 2400-05-020 |
| Company DUNS | 601306413 |
| Company Name | Medshape, 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | M97024000502006 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
[M97024000502006]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2016-01-06 |
| M97024000502006 | Quick Connect Driver, 2.0 Reverse Threaded |
| M970140020047500 | 4.75MM X 20MM PEEK Interference Screw |
| M970140017047500 | 4.75MM X 17.5MM PEEK Interference Screw |
| M970140015047500 | 4.75MM X 15MM PEEK Interference Screw |