Primary Device ID | 00684995510036 |
NIH Device Record Key | c58a6711-c885-41c6-b8b9-18693312a84d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Silicone T-Tube |
Version Model Number | SU130-1228 |
Company DUNS | 080524654 |
Company Name | BENTEC MEDICAL OPCO, LLC |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00684995510036 [Primary] |
PTT | Biliary Catheter For Irrigation And Contrast Injection, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-30 |
Device Publish Date | 2023-10-20 |
00684995510104 | 7 Fr. x 12 in L |
00684995510098 | 5 Fr. x 12 in L |
00684995510081 | 3 Fr. x 12 in L |
00684995510074 | 2 Fr. x 12 in L |
00684995510067 | 16 Fr. x 12 in L |
00684995510050 | 14 Fr. x 12 in L |
00684995510043 | 12 Fr. x 12 in L |
00684995510036 | 10 Fr. x 12 in L |
00684995510029 | 8 Fr. x 12 in L |
00684995510012 | 6 Fr. x 12 in L |
00684995510005 | 4 Fr. x 12 in L |