Primary Device ID | M648C1102001 |
NIH Device Record Key | a82a0ba8-def4-4a97-9932-31a8f74a0a67 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ONETRAC LXS |
Version Model Number | C110200 |
Catalog Number | C110200 |
Company DUNS | 011560431 |
Company Name | OBP CORPORATION |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M648C1102000 [Primary] |
HIBCC | M648C1102001 [Package] Contains: M648C1102000 Package: BOX [1 Units] In Commercial Distribution |
HIBCC | M648C1102002 [Package] Package: CARTON [10 Units] In Commercial Distribution |
JOL | Catheter And Tip, Suction |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-20 |
Device Publish Date | 2021-04-12 |
M648C1102001 | ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
M648C1102201 | ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
M648C1102101 | ONETRAC LXS SUCTION, METAL TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |