| Primary Device ID | 00814913020501 | 
| NIH Device Record Key | 054e7d82-bd99-49dc-8a9e-277d3e1c2a00 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ET II Fixture SA Regular Pre-Mounted | 
| Version Model Number | AET2R5018S | 
| 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 | 00814913020501 [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 | 2015-09-01 | 
| 00814913020501 | AET2R5018S | 
| 00814913020495 | AET2R5015S | 
| 00814913020488 | AET2R5013S | 
| 00814913020471 | AET2R5011S | 
| 00814913020464 | AET2R5010S | 
| 00814913020457 | AET2R5008S | 
| 00814913020440 | AET2R5007S | 
| 00814913020426 | AET2R4518S | 
| 00814913020419 | AET2R4515S | 
| 00814913020402 | AET2R4513S | 
| 00814913020396 | AET2R4511S | 
| 00814913020389 | AET2R4510S | 
| 00814913020372 | AET2R4508S | 
| 00814913020365 | AET2R4507S | 
| 00814913020358 | AET2R4018S | 
| 00814913020341 | AET2R4015S | 
| 00814913020334 | AET2R4013S | 
| 00814913020327 | AET2R4011S | 
| 00814913020310 | AET2R4010S | 
| 00814913020303 | AET2R4008S | 
| 00814913020297 | AET2R4007S |