| Primary Device ID | 05711117080490 | 
| NIH Device Record Key | 27bdae0d-7896-4171-8ec7-529e2a9f3f38 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Sanibel Supply | 
| Version Model Number | Ear tip, umbrella 10 mm, blue | 
| Company DUNS | 306308354 | 
| Company Name | Interacoustics A/S | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05711117080490 [Package] Contains: 05711117229370 Package: [25 Units] In Commercial Distribution | 
| GS1 | 05711117080506 [Package] Contains: 05711117229370 Package: [100 Units] In Commercial Distribution | 
| GS1 | 05711117229370 [Primary] | 
| ETT | Cushion, Earphone (For Audiometric Testing) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2025-06-30 | 
| Device Publish Date | 2022-12-08 | 
| 05711117221848 | EARturtle | 
| 05711117223101 | ADI eartip sample kit, E3 | 
| 05711117221107 | ADI eartip sample kit, Oaktree | 
| 05711117208238 | ADI eartip sample kit | 
| 05711117080391 | Ear tip, mushroom 14 mm, red | 
| 05711117080414 | Ear tip, mushroom 15 mm, blue | 
| 05711117229240 | Preemie Ear tip, green | 
| 05711117229257 | Flanged infant eartips 3-5 mm, red | 
| 05711117080438 | Ear tip, mushroom 19 mm, yellow | 
| 05711117229318 | Ear tip, mushroom 13 mm, green | 
| 05711117080353 | Ear tip, mushroom 12 mm, yellow | 
| 05711117229301 | Ear tip, mushroom 11 mm, blue | 
| 05711117080315 | Ear tip, mushroom 10 mm, red | 
| 05711117217223 | AuDX Preemie ear Tip 3 mm, light red | 
| 05711117217230 | AuDX Tree ear tip 3,5-5 mm transparent | 
| 05711117217247 | AuDX Infant ear tip 6 mm, light blue | 
| 05711117123524 | Ear tip 4.5 mm, AOT-4.5 pink | 
| 05711117229271 | Flanged infant eartips 5-8 mm, yellow | 
| 05711117229264 | Flanged infant eartips 4-7 mm, blue | 
| 05711117229295 | Ear tip, mushroom 9 mm, green | 
| 05711117080636 | Ear tip, mushroom 8 m, yellow | 
| 05711117229288 | Ear tip, mushroom 7mm, blue | 
| 05711117080599 | Ear tip, umbrella 22 mm, yellow | 
| 05711117080575 | Ear tip, umbrella 19 mm, blue | 
| 05711117080551 | Ear tip, umbrella 15 mm, red | 
| 05711117080537 | Ear tip, umbrella 13 mm, green | 
| 05711117080513 | Ear tip, umbrella 11 mm, yellow | 
| 05711117080490 | Ear tip, umbrella 10 mm, blue | 
| 05711117080476 | Ear tip, umbrella 9 mm, green | 
| 05711117080452 | Ear tip, umbrella 7,5 mm, green | 
| 05711117229745 | Ear tip, OAE-3, 3 mm yellow | 
| 05711117225297 | Sanibel foam tip, medium, adult pink | 
| 05711117225259 | Sanibel foam tip, small, peadiatric pink | 
| 05711117217179 | Jumbo OAE foam ear tips | 
| 05711117217162 | Adult OAE foam ear tips | 
| 05711117217155 | Pediatric OAE foam ear tips | 
| 05711117222128 | Ear tip Infant C, transparent | 
| 05711117222104 | Ear tip Infant A, transparent | 
| 05711117228656 | Sanibel foam tip, large, Jumbo pink | 
| 05711117227796 | Audiometric foam ear tip | 
| 05711117123500 | Ear tip 3.7 mm, AOT-3.7 yellow | 
| 05711117129267 | ANA Infant mushroom ear tip, green | 
| 05711117129274 | ANA-Infant Tree, yellow | 
| 05711117123548 | Ear tip 4-7 mm, AOT 4-7 transparent | 
| 05711117123517 | Ear tip 4 mm, AOT-4.0 green | 
| 05711117123531 | Ear tip 5 mm, AOT-5.0 light blue | 
| 05711117123470 | Ear tip infant 4,5 mm, ANA-4.5, red-brown | 
| 05711117123494 | Ear tip infant 5 mm, ANA-5.0, green | 
| 05711117123487 | Ear tip infant 4 mm, ANA-4.0, blue | 
| 05711117221305 | SnapPROBE™ Accessories box |