Primary Device ID | 06957277200340 |
NIH Device Record Key | ea016fd8-54a6-4c70-81ea-b9ede95a2afd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AWI |
Version Model Number | 209-00-47 |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06957277200340 [Primary] |
GS1 | 16957277200347 [Unit of Use] |
FQH | Lavage, Jet |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-11-06 |
Device Publish Date | 2019-07-22 |
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 |