| Primary Device ID | 10818614022427 |
| NIH Device Record Key | 89c3dce0-56b7-456b-998c-bac66f0b12cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | itto |
| Version Model Number | 52-10102 |
| Company DUNS | 117630237 |
| Company Name | Maruho Medical, 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 | false |
| Expiration Date | true |
| 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 |
|---|---|
| GS1 | 00818614022420 [Primary] |
| GS1 | 10818614022427 [Package] Contains: 00818614022420 Package: box [8 Units] In Commercial Distribution |
| NBH | Accessories, Arthroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-04 |
| Device Publish Date | 2021-09-24 |
| 10818614022434 | Itto S+L shuttle and loop for use with itto CSP 20 in size 1 UHMWPE |
| 10818614022427 | Itto S+L shuttle and loop for use with itto CSP 2 in size 1 UHMWPE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ITTO 90696803 not registered Live/Pending |
Maruho Medical, Inc. 2021-05-07 |
![]() ITTO 79383593 not registered Live/Pending |
NAKAJO HARDWARE Co., Ltd. 2023-10-11 |
![]() ITTO 79092780 4062036 Live/Registered |
GUANGDONG WINTO CERAMICS CO., LTD. 2010-09-24 |