Primary Device ID | 10684995540276 |
NIH Device Record Key | 2ed74721-9db2-4add-9bda-bc06b9a8fed5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Silicone Tubing, Radiopaque |
Version Model Number | GS75160-47SP12 |
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 | 00684995540279 [Primary] |
GS1 | 10684995540276 [Package] Contains: 00684995540279 Package: [10 Units] In Commercial Distribution |
GBX | Catheter, Irrigation |
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 |
10684995540313 | 12 Fr. x 8’’ |
10684995540306 | 10 Fr. x 8’’ |
10684995540276 | 7 Fr. x 12’’ |
10684995540269 | 7 Fr. x 4’’ |
10684995540252 | 6 Fr. x 12’’ |
10684995540221 | 5 Fr. x 8’’ |
10684995540214 | 8 Fr. x 8’’ |
10684995540207 | 8 Fr. x 4’’ |
10684995540191 | 6 Fr. x 8’’ |
00684995540187 | 24 Fr. x 100 cm |
00684995540170 | 20 Fr. x 100 cm |
00684995540163 | 20 Fr. x 100 cm |
00684995540149 | 18 Fr. x 100 cm |
00684995540132 | 16 Fr. x 100 cm |
00684995540118 | 14 Fr. x 100 cm |
00684995540095 | 11 Fr. x 100 cm |
00684995540088 | 10 Fr. x 100 cm |
00684995540071 | 9 Fr. x 100 cm |
00684995540064 | 8 Fr. x 100 cm |
00684995540057 | 7 Fr. x 100 cm |
00684995540040 | 6 Fr. x 100 cm |
00684995540033 | 5 Fr. x 100 cm |
00684995540026 | 4 Fr. x 100 cm |
00684995540019 | 3 Fr. x 100 cm |
00684995540002 | 2 Fr. x 100 cm |