| Primary Device ID | 04250381804032 |
| NIH Device Record Key | 75c2f1ac-ab4d-4870-8624-6d2c237c10d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Total Middle Ear Implants |
| Version Model Number | 11840 |
| Catalog Number | 11840 |
| 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 | 4 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250381804032 [Primary] |
| ETA | Replacement, Ossicular Prosthesis, Total |
| 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 |