| Primary Device ID | 04250381805152 |
| NIH Device Record Key | 7db84480-fe8e-40c9-a20d-aa938df11ffe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Partial Middle Ear Implants |
| Version Model Number | 12820 |
| Catalog Number | 12820 |
| Company DUNS | 332893028 |
| Company Name | Spiggle & Theis Medizintechnik GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 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 | +492206908153 |
| p.stockmann@spiggle-theis.com |
| Length | 2 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Storage must protect from dust, moisture and contamination. Avoid direct Sunlight during storage. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250381805152 [Primary] |
| ETB | Prosthesis, Partial Ossicular Replacement |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-17 |
| Device Publish Date | 2019-06-07 |
| 04250381821503 - Gillies skin hook | 2025-10-07 fine 18.5 cm |
| 04250676710017 - Hook | 2025-10-07 curved, blunt 10.5 cm |
| 04250676711625 - Fork | 2025-10-07 curved 10.5 cm |
| 04250676716880 - ENT-single-use suction tubes, angled | 2025-10-07 transparent, Luer-Lock 130 x 2.0 mm, sterile, box of 50 |
| 04250676716897 - ENT-single-use suction tubes, angled | 2025-10-07 blue, Luer-Lock 130 x 3.0 mm, sterile, box of 50 |
| 04250676731982 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.5 mm diameter |
| 04250676731999 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.6 mm diameter |
| 04250676732002 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.8 mm diameter |