| Primary Device ID | 07630031718167 | 
| NIH Device Record Key | b6db4579-c1c7-4921-ba05-8af9aa25be96 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | STRAUMANN ORTHOSYSTEM | 
| Version Model Number | 1 | 
| Catalog Number | 042.335S | 
| Company DUNS | 483599259 | 
| Company Name | Institut Straumann AG | 
| 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 | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)448-8168 | 
| info.usa@straumann.com | 
| Outer Diameter | 4.1 Millimeter | 
| Length | 4.2 Millimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07630031718167 [Primary] | 
| OAT | Implant, endosseous, orthodontic | 
| 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 | 2015-09-24 | 
| 07630031722713 | Healing cap, palatal implant, D 4.8mm, H 3.5mm, PEEK | 
| 07630031722706 | Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel | 
| 07630031722690 | Cap with transpalatal arch, palatal implant, D 4.8mm, H 3.5mm, stainless steel | 
| 07630031722683 | Cap, palatal implant, D 4.8mm, H 5.5mm, stainless steel | 
| 07630031722676 | Cap, palatal implant, D 4.8mm, H 3.5mm, stainless steel | 
| 07630031718174 | Palatal Implant D 4.8 mm SLA 4.2 mm, Ti | 
| 07630031718167 | Palatal Implant D 4.1 mm SLA 4.2 mm, Ti |