| Primary Device ID | 10842430116756 |
| NIH Device Record Key | 63d6e2c5-f9c2-4451-af5a-c6a455b111e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PKIT PROAXIS LPC SG HIP ARM |
| Version Model Number | 6988A-PC-1 |
| Company DUNS | 084527241 |
| Company Name | MIZUHO ORTHOPEDIC SYSTEMS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842430116759 [Primary] |
| GS1 | 10842430116756 [Package] Contains: 00842430116759 Package: Multi-pack [6 Units] In Commercial Distribution |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-29 |
| Device Publish Date | 2026-01-21 |
| 10842430116749 - PKIT, STS Trios, LPC, SG ARM PAD | 2026-01-29 |
| 10842430116756 - PKIT PROAXIS LPC SG HIP ARM | 2026-01-29 |
| 10842430116756 - PKIT PROAXIS LPC SG HIP ARM | 2026-01-29 |
| 00842430109188 - PRONECONNECT PROTECTIVE HELMET | 2025-09-08 |
| 00842430109195 - PRONECONNECT ADJUSTABLE HELMET | 2025-09-08 |
| 00842430109201 - PRONECONNECT COMBO PACK 4L, 3M, 3S | 2025-09-08 |
| 00842430109218 - PRONECONNECT LOW PROFILE MIRROR | 2025-09-08 |
| 00842430109225 - PRONECONNECT ADJUSTABLE MIRROR | 2025-09-08 |
| 00842430109232 - PRONECONNECT MIRROR WITH POST HOLES | 2025-09-08 |