| Primary Device ID | 17310236040412 |
| NIH Device Record Key | b3ea9876-e012-4cb5-9554-b1f3d6d5f65d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoForm |
| Version Model Number | 12 Distal |
| Catalog Number | 604041 |
| Company DUNS | 353954381 |
| Company Name | Directa AB |
| 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 | false |
| 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 | 17310236040412 [Primary] |
| ELZ | Crown, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 17310236040511 | 41-42 Distal |
| 17310236040504 | 41-42 Mesial |
| 17310236040498 | 31-32 Distal |
| 17310236040481 | 31-32 Mesial |
| 17310236040474 | 23 Distal |
| 17310236040467 | 23 Mesial |
| 17310236040450 | 13 Distal |
| 17310236040443 | 13 Mesial |
| 17310236040436 | 22 Distal |
| 17310236040429 | 22 Mesial |
| 17310236040412 | 12 Distal |
| 17310236040405 | 12 Mesial |
| 17310236040399 | 21 Distal |
| 17310236040382 | 21 Mesial |
| 17310236040375 | 11 Distal |
| 17310236040368 | 11 Mesial |
| 17310236040351 | Assortment A |
| 17310236040344 | Assortment B |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COFORM 98769634 not registered Live/Pending |
Precise Coatings Technology EIN 99-2616461 2024-09-25 |
![]() COFORM 85610716 not registered Dead/Abandoned |
ENCAP Technologies, LLC 2012-04-27 |
![]() COFORM 85424497 4238958 Dead/Cancelled |
Ansell Limited 2011-09-16 |
![]() COFORM 79382727 not registered Live/Pending |
Directa AB 2023-10-11 |
![]() COFORM 72374796 0939722 Dead/Cancelled |
CONTINENTAL SCREW COMPANY 1970-10-30 |