Primary Device ID | 00813110025838 |
NIH Device Record Key | be4a9ce8-e506-4b6a-9bad-0e0bb42866d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trephine |
Version Model Number | 260-801-837 |
Catalog Number | 260-801-837 |
Company DUNS | 945015758 |
Company Name | BICON, 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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813110025838 [Primary] |
EJL | Bur, Dental |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00813110025838]
Moist Heat or Steam Sterilization
[00813110025838]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-03-25 |
Device Publish Date | 2016-05-06 |
00813110025883 | 8.0mm Trephine |
00813110025876 | 7.0mm Trephine |
00813110025869 | 6.0mm Trephine |
00813110025852 | 5.25mm Trephine |
00813110025845 | 4.25mm Trephine |
00813110025838 | 3.75mm Trephine (4.6mm OD) |
00813110025821 | 10mm Trephine |