Primary Device ID | 00813110026149 |
NIH Device Record Key | 7c2ee420-e02e-43d7-b632-8b4b159cf721 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guided Surgery |
Version Model Number | 260-930-005 |
Catalog Number | 260-930-005 |
Company DUNS | 945015758 |
Company Name | BICON, LLC |
Device Count | 5 |
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 | 00813110026149 [Primary] |
GS1 | 10813110026146 [Unit of Use] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00813110026149]
Moist Heat or Steam Sterilization
[00813110026149]
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 | 2016-06-10 |
00813110026514 | 5.0mm Guided Surgery Rings |
00813110026415 | 4.5mm Guided Surgery Rings |
00813110026309 | 4.0mm Guided Surgery Rings |
00813110026149 | 3.0mm Guided Surgery Rings |
00813110024596 | 6.0mm Guided Surgical Kit |
00813110024589 | 5.0mm Guided Surgical Kit |
00813110024572 | 4.5mm Guided Surgical Kit |
00813110024565 | 4.0mm Guided Surgical Kit |
00813110024541 | 3.5mm Guided Surgical Kit |
00813110024534 | 3.0mm Guided Surgical Kit |
00813110028082 | 2.0 x 11.0mm Guided Pilot Drill |
00813110028075 | 2.0 x 8.0mm Guided Pilot Drill |
00813110028068 | 2.0 x 6.0mm Guided Pilot Drill |
00813110028051 | 2.0 x 5.0mm Guided Pilot Drill |
00813110028266 | 2.0mm Guided Pilot Kit |
00813110028044 | 2.0mm Guided Surgery Rings |