Primary Device ID | B033KCW61 |
NIH Device Record Key | ccc03f39-beac-473d-a941-2d72be5f7aed |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Seitz Solution Radial Head |
Version Model Number | KCW-61 |
Catalog Number | KCW-61 |
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 | B033KCW61 [Primary] |
KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B033KCW61]
Moist Heat or Steam Sterilization
[B033KCW61]
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 |