Primary Device ID | 00813110023483 |
NIH Device Record Key | a5f4a56f-7a73-40e0-a65a-0aae693896e4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fixed-Detachable Component |
Version Model Number | 260-100-005 |
Catalog Number | 260-100-005 |
Company DUNS | 945015758 |
Company Name | BICON, LLC |
Device Count | 4 |
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 | 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 | 00813110023483 [Primary] |
GS1 | 10813110023480 [Unit of Use] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-03-25 |
Device Publish Date | 2016-09-19 |
00813110023568 | 3.0mm Hex Cover Screw |
00813110023551 | Hex Retention Screw |
00813110023544 | Metal Transfer Coping |
00813110023537 | 10mm Hex Coping Screw |
00813110023520 | 5.0mm Hex Coping Screw |
00813110023490 | Fixed-Detachable Abutment Analog |
00813110023483 | Plastic Transfer Coping |
00813110027610 | Titanium Coping (2) |