| Primary Device ID | 00814913024639 | 
| NIH Device Record Key | 10dfe1d5-73c0-4a61-82f3-7da403c47f20 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ET II Fixture SA Regular No-Mounted | 
| Version Model Number | CET2R4018S | 
| Company DUNS | 796083090 | 
| Company Name | HIOSSEN, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| 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 | true | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00814913024639 [Primary] | 
| DZE | Implant, Endosseous, Root-Form | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2017-11-17 | 
| 00814913024776 | CET2R5015S | 
| 00814913024769 | CET2R5013S | 
| 00814913024752 | CET2R5011S | 
| 00814913024745 | CET2R5010S | 
| 00814913024738 | CET2R5008S | 
| 00814913024721 | CET2R5007S | 
| 00814913024714 | CET2R5006S | 
| 00814913024691 | CET2R4515S | 
| 00814913024684 | CET2R4513S | 
| 00814913024677 | CET2R4511S | 
| 00814913024660 | CET2R4510S | 
| 00814913024653 | CET2R4508S | 
| 00814913024646 | CET2R4507S | 
| 00814913024639 | CET2R4018S | 
| 00814913024622 | CET2R4015S | 
| 00814913024615 | CET2R4013S | 
| 00814913024608 | CET2R4011S | 
| 00814913024592 | CET2R4010S | 
| 00814913024585 | CET2R4008S | 
| 00814913024578 | CET2R4007S |