| Primary Device ID | 04250676743473 |
| NIH Device Record Key | 810d4d40-92c0-45b6-acea-398b212d141e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inflation device |
| Version Model Number | 2080-9030040-US |
| Catalog Number | 2080-9030040-US |
| Company DUNS | 332893028 |
| Company Name | Spiggle & Theis Medizintechnik GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250676743473 [Primary] |
| PNZ | Eustachian tube balloon dilation device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2023-09-07 |
| 04250676739988 - Jackson laryngoscope | 2025-01-07 size 3, handle removable, light carrier satin finished inside, 180 mm long |
| 04250676742056 - Blakesley nasal forceps, comfort | 2025-01-06 straight, golden button 4.0 mm, 12 cm |
| 04250676742353 - Aufricht nasal retractor | 2025-01-06 for holding of suction tube 18.5 cm |
| 04250676742360 - Suction tube | 2025-01-06 for Aufricht nasal retractor 18.5 cm |
| 04250676744234 - Aufricht nasal retractor | 2025-01-06 including suction tube 18.5 cm |
| 04250381814116 - Kerrison sphenoid punch | 2024-11-19 40° downw., golden tip, totally detach. 1 mm, 18 cm |
| 04250676725561 - Kerrison sphenoid punch | 2024-11-19 90° upw., golden tip, totally detachable 1 mm, 23 cm |
| 04250676725974 - Kerrison sphenoid punch | 2024-11-19 40° upw., golden tip, totally detachable 1 mm, 20 cm |