TubaVent® short wide 2080-12364520-US
GUDID 04250676743510
Spiggle & Theis Medizintechnik GmbH
Eustachian catheter, single-use| Primary Device ID | 04250676743510 |
| NIH Device Record Key | 3960a31b-60d0-4ac3-8e31-571eeb5a6be0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TubaVent® short wide |
| Version Model Number | 2080-12364520-US |
| Catalog Number | 2080-12364520-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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250676743510 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223542
FDA Product Code
| PNZ | Eustachian tube balloon dilation device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2023-09-07 |
Devices Manufactured by Spiggle & Theis Medizintechnik GmbH
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| 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 |
| 04250676726865 - Caversaccio Tympano Sizer | 2024-11-19 shaft angled 6 mm, black coated |
| 04250676730756 - Schnidt tonsil forceps | 2024-11-19 one ring open, slender strongly curved, 19 cm |
| 04250676740823 - Castroviejo micro needle holder | 2024-11-19 straight, smooth, flat type handles with ratchet, 14 cm |
| 04250676739971 - Jackson laryngoscope | 2024-11-07 size 2, handle removable, light carrier satin finished inside, 171 mm long |
| 04250676740670 - Bowman salivary duct probe | 2024-08-26 size 3/4, 1.3/1.4, silver 12.5 cm |
Trademark Results [TubaVent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TUBAVENT 79343451 not registered Live/Pending |
Spiggle & Theis Medizintechnik GmbH 2022-05-16 |
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