| Primary Device ID | 04056839016428 | 
| NIH Device Record Key | 40ffae13-a3fe-49c1-ae5f-09a360df6a55 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Audio Service | 
| Version Model Number | HA SUN 16 G4 GNT | 
| Catalog Number | 10946021 | 
| Company DUNS | 157412271 | 
| Company Name | SIVANTOS, INC. | 
| 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 | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | false | 
| 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 | 
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | |
| Phone | 17325626600 | 
| consumerrelations@sivantos.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04056839016428 [Primary] | 
| ESD | Hearing Aid, Air Conduction | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-06-11 | 
| Device Publish Date | 2018-05-09 | 
| 04056839016541 | Audio Service HA SUN 8 G4 SLV Hearing Aid | 
| 04056839016534 | Audio Service HA SUN 8 G4 SB Hearing Aid | 
| 04056839016527 | Audio Service HA SUN 8 G4 PRL Hearing Aid | 
| 04056839016510 | Audio Service HA SUN 8 G4 GR Hearing Aid | 
| 04056839016503 | Audio Service HA SUN 8 G4 GNT Hearing Aid | 
| 04056839016497 | Audio Service HA SUN 8 G4 DGT Hearing Aid | 
| 04056839016480 | Audio Service HA SUN 8 G4 BRN Hearing Aid | 
| 04056839016473 | Audio Service HA SUN 8 G4 BG Hearing Aid | 
| 04056839016466 | Audio Service HA SUN 16 G4 SLV Hearing Aid | 
| 04056839016459 | Audio Service HA SUN 16 G4 SB Hearing Aid | 
| 04056839016442 | Audio Service HA SUN 16 G4 PRL Hearing Aid | 
| 04056839016435 | Audio Service HA SUN 16 G4 GR Hearing Aid | 
| 04056839016428 | Audio Service HA SUN 16 G4 GNT Hearing Aid | 
| 04056839016411 | Audio Service HA SUN 16 G4 DGT Hearing Aid | 
| 04056839016404 | Audio Service HA SUN 16 G4 BRN Hearing Aid | 
| 04056839016398 | Audio Service HA SUN 16 G4 BG Hearing Aid | 
| 04056839016381 | Audio Service HA SUN 12 G4 SLV Hearing Aid | 
| 04056839016374 | Audio Service HA SUN 12 G4 SB Hearing Aid | 
| 04056839016367 | Audio Service HA SUN 12 G4 PRL Hearing Aid | 
| 04056839016350 | Audio Service HA SUN 12 G4 GR Hearing Aid | 
| 04056839016343 | Audio Service HA SUN 12 G4 GNT Hearing Aid | 
| 04056839016336 | Audio Service HA SUN 12 G4 DGT Hearing Aid | 
| 04056839016329 | Audio Service HA SUN 12 G4 BRN Hearing Aid | 
| 04056839016312 | Audio Service HA SUN 12 G4 BG Hearing Aid | 
| 04056839016060 | Audio Service HA TUNE T SUN G4 SLV Hearing Aid | 
| 04056839015841 | Audio Service HA HP 6 G4 GR Hearing Aid | 
| 04056839015261 | Audio Service HA TUNE SUN G4 SLV Hearing Aid | 
| 04056839015254 | Audio Service HA TUNE SUN G4 SB Hearing Aid | 
| 04056839015247 | Audio Service HA TUNE SUN G4 PRL Hearing Aid | 
| 04056839015230 | Audio Service HA TUNE SUN G4 GR Hearing Aid | 
| 04056839015223 | Audio Service HA TUNE SUN G4 GNT Hearing Aid | 
| 04056839015216 | Audio Service HA TUNE SUN G4 BRN Hearing Aid | 
| 04056839015209 | Audio Service HA TUNE SUN G4 DGT Hearing Aid | 
| 04056839015193 | Audio Service HA TUNE SUN G4 BG Hearing Aid | 
| 04056839014844 | Audio Service HA TUNE T HP G4 GR Hearing Aid | 
| 04056839014745 | Audio Service S_ITE QUIX M T3MOC L BG Hearing Aid | 
| 04056839014738 | Audio Service S_ITE QUIX M T3MOC R BG Hearing Aid | 
| 04056839014516 | Audio Service HA HP 4 G4 GR Hearing Aid | 
| 04056839014509 | Audio Service HA HP 4 G4 DBR Hearing Aid | 
| 04056839014493 | Audio Service HA HP 4 G4 DGT Hearing Aid | 
| 04056839014486 | Audio Service HA HP 4 G4 BG Hearing Aid | 
| 04056839014479 | Audio Service HA HP 6 G4 DBR Hearing Aid | 
| 04056839014462 | Audio Service HA HP 6 G4 DGT Hearing Aid | 
| 04056839014455 | Audio Service HA HP 6 G4 BG Hearing Aid | 
| 04056839014165 | Audio Service HA TUNE HP G4 GR Hearing Aid | 
| 04056839014158 | Audio Service HA TUNE HP G4 DBR Hearing Aid | 
| 04056839014141 | Audio Service HA TUNE HP G4 DGT Hearing Aid | 
| 04056839014134 | Audio Service HA TUNE HP G4 BG Hearing Aid | 
| 04056839014127 | Audio Service HA HP 8 G4 GR Hearing Aid | 
| 04056839014110 | Audio Service HA HP 8 G4 DBR Hearing Aid | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() AUDIO SERVICE  79111753  4270368 Live/Registered  | 
        Sivantos Pte. Ltd.  2012-02-07  |