| Primary Device ID | B033KCHI2010 |
| NIH Device Record Key | 42c246eb-ee7a-4baa-8a23-5293cb47e08c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Seitz Solution Radial Head |
| Version Model Number | KCHI-2010 |
| Catalog Number | KCHI-2010 |
| Company DUNS | 004171112 |
| Company Name | Kapp Surgical Instrument Co. |
| 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 | 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 | B033KCHI2010 [Primary] |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B033KCHI2010]
Moist Heat or Steam Sterilization
[B033KCHI2010]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
| B033KCW92 | 9x2mm Spacer |
| B033KCW91 | 9x1mm Spacer |
| B033KCW82 | 8x2mm Spacer |
| B033KCW81 | 8x1mm Spacer |
| B033KCW72 | 7x2mm Spacer |
| B033KCW71 | 7x1mm Spacer |
| B033KCW62 | 6x2mm Spacer |
| B033KCW61 | 6x1mm Spacer |
| B033KCW52 | 5x2mm Spacer |
| B033KCW51 | 5x1mm Spacer |
| B033KCSI925 | 9x25.5mm Stem |
| B033KCSI824 | 8x24mm Stem |
| B033KCSI722 | 7x22mm Stem |
| B033KCSI621 | 6x21mm Stem |
| B033KCSI519 | 5x19mm Stem |
| B033KCHI2616 | 26x16mm Radial Head |
| B033KCHI2614 | 26x14mm Radial Head |
| B033KCHI2612 | 26x12mm Radial Head |
| B033KCHI2315 | 23x15mm Radial Head |
| B033KCHI2313 | 23x13mm Radial Head |
| B033KCHI2311 | 23x11mm Radial Head |
| B033KCHI2014 | 20x14mm Radial Head |
| B033KCHI2012 | 20x12mm Radial Head |
| B033KCHI2010 | 20x10mm Radial Head |
| B033KCHI1813 | 18 x 13mm Radial Head |
| B033KCHI1811 | 18 x 11mm Radial Head |
| B033KCHI1809 | 18 x 9mm Radial Head |