| Primary Device ID | 10842430111539 |
| NIH Device Record Key | 3abc53c8-5a13-4692-aa91-e0ad02afb525 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PKIT, INDIV W/SHEARGARD, SST-3000 (1) |
| Version Model Number | 5819-1 |
| Catalog Number | 5819 |
| 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 | true |
| 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 | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com | |
| Phone | 1-800-777-4674 |
| CustServ@mizuhosi.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842430111532 [Primary] |
| GS1 | 10842430111539 [Package] Contains: 00842430111532 Package: multi-pack [6 Units] In Commercial Distribution |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-05-20 |
| Device Publish Date | 2022-01-05 |