| Primary Device ID | 16957277200712 |
| NIH Device Record Key | 59d1c7f5-f6df-4d61-acb2-a2e5a85a41c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AWI |
| Version Model Number | 209-04 |
| Catalog Number | 209-04 |
| Company DUNS | 529936792 |
| Company Name | Apex (Guangzhou) Tools & Orthopedics Co. |
| Device Count | 10 |
| 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 | 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 | 06957277200739 [Primary] |
| GS1 | 16957277200712 [Unit of Use] |
| FQH | Lavage, Jet |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-08 |
| Device Publish Date | 2021-03-31 |
| 06957277200692 | PULSE IRRIGATOR |
| 06957277200449 | HYDRA ADAPTOR |
| 06957277200371 | STANDARD TIP |
| 06957277200364 | STANDARD TIP |
| 06957277200357 | STANDARD TIP |
| 06957277200340 | TUNNEL TIP |
| 06957277200333 | PULSE IRRIGATOR |
| 06957277200326 | PULSE IRRIGATOR |
| 16957277200804 | TRUNK-S IRRIGATION BAG |
| 06957277200814 | TRUNK-S IRRIGATION BAG |
| 16957277200774 | TRUNK-L IRRIGATION KIT |
| 06957277200784 | TRUNK-L IRRIGATION KIT |
| 16957277200743 | TRUNK-S IRRIGATION KIT |
| 06957277200753 | TRUNK-S IRRIGATION KIT |
| 16957277200712 | EXTREMITY IRRIGATION KIT |
| 06957277200722 | EXTREMITY IRRIGATION KIT |
| 16957277200682 | PULSE IRRIGATOR WITH HYDRA ADAPTOR |
| 16957277201597 | TRUNK IRRIGATION BAG |
| 16957277201580 | EXTREMITY IRRIGATION BAG |
| 16957277200354 | STANDARD TIP |
| 06957277202610 | SACRAL/TRUNK/BODY KIT |
| 06957277202603 | EXTREMITY/ARMS/LEGS KIT |