| Primary Device ID | E494761102R1 | 
| NIH Device Record Key | 24bd274c-d54b-4dec-8640-1f308b407c19 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ceramill Sintron® | 
| Version Model Number | Sintron R 71 XS (12 mm) | 
| Catalog Number | 761102R | 
| Company DUNS | 300708950 | 
| Company Name | Amann Girrbach AG | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | true | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | |
| Phone | +43552362333105 | 
| austria@amanngirrbach.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | E494761102R1 [Primary] | 
| EJH | Alloy, Metal, Base | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-06-30 | 
| E4947616051 | Sintron ZZ 95x20 | 
| E4947616041 | Sintron ZZ 95x18 | 
| E4947616031 | Sintron ZZ 95x16 | 
| E4947616021 | Sintron ZZ 95x14 | 
| E4947616011 | Sintron ZZ 95x12 | 
| E4947616001 | Sintron ZZ 95x10 | 
| E4947611531 | Sintron Multi 18 mm (2 pcs) | 
| E4947611511 | Sintron Multi 15,3 mm (2 pcs) | 
| E4947611321 | Sintron 98x 10 N | 
| E4947611301 | Sintron 98x 12 N | 
| E4947611281 | Sintron 98x 14 N | 
| E4947611261 | Sintron 98x 16 N | 
| E4947611241 | Sintron 98x 18 N | 
| E4947611221 | Sintron 98x 20 N | 
| E4947611201 | Sintron 98x 25 N | 
| E494761107RSTM1 | Sintron 25mm | 
| E494761107R1 | Sintron R 71 XL (25mm) | 
| E494761106RSTM1 | Sintron 20mm | 
| E494761106RIDC1 | IDC sintron 20mm | 
| E494761106R1 | Sintron R 71 L (20 mm) | 
| E494761105RSTM1 | Sintron 18mm | 
| E494761105RIDC1 | IDC sintron 18mm | 
| E494761105R1 | Sintron R 71 M (18 mm) | 
| E494761104RSTM1 | Sintron 16mm | 
| E494761104RIDC1 | IDC sintron 16mm | 
| E494761104R1 | Sintron R 71 (16 mm) | 
| E494761103RSTM1 | Sintron 14mm | 
| E494761103RIDC1 | IDC sintron 14mm | 
| E494761103R1 | Sintron R 71 S (14 mm) | 
| E494761102RSTM1 | Sintron 12mm | 
| E494761102RIDC1 | IDC sintron 12mm | 
| E494761102R1 | Sintron R 71 XS (12 mm) | 
| E494761101RSTM1 | Sintron 10mm | 
| E494761101RIDC1 | IDC sintron 10mm | 
| E494761101R1 | Sintron R 71 XXS (10 mm) | 
| E4947600171 | Sintron Starterkit for CM2 | 
| E4947600161 | Sintron Starterkit for CM1 | 
| E4947560003M1 | Sintron Multi (18 mm) | 
| E4947550003M1 | Sintron Multi (15,3 mm) | 
| E4947675231 | Ceramill Sintron 98x25 F | 
| E4947675221 | Ceramill Sintron 98x20 F | 
| E4947675211 | Ceramill Sintron 98x18 F | 
| E4947675201 | Ceramill Sintron 98x16 F | 
| E4947675191 | Ceramill Sintron 98x14 F | 
| E4947675181 | Ceramill Sintron 98x12 F | 
| E4947675171 | Ceramill Sintron 98x10 F | 
| E4947616061 | Sintron ZZ 95x25 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() CERAMILL SINTRON  85778169  4570668 Live/Registered  | 
        Amann Girrbach AG  2012-11-13  |