Hoffman
GUDID 00763000034634
VENT TUBE 1028080 HOFFMAN PERMANENT
MEDTRONIC XOMED, INC.
Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube| Primary Device ID | 00763000034634 |
| NIH Device Record Key | 6448946a-f8fe-48e0-9053-0755e4e71784 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hoffman |
| Version Model Number | 1028080 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
| Lumen/Inner Diameter | 1.25 Millimeter |
| Length | 8.3 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000034634 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151067
FDA Product Code
| ETD | TUBE, TYMPANOSTOMY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-11 |
On-Brand Devices [Hoffman]
| 00681490030052 | VENT TUBE 1028080 HOFFMAN PERMANENT |
| 00763000034634 | VENT TUBE 1028080 HOFFMAN PERMANENT |
Trademark Results [Hoffman]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.