Identity
- Trade Name
- SUPERSOFT™ T-TUBE FDA UDI
- Generic Name
- Tympanostomy tube FDA UDI
- Device Name
- SUPERSOFT™ T-TUBE 1.14MM ID X 8MM LENGTH SILICONE 5 PACK FDA UDI
- Model / Reference
- 510-361 FDA UDI
- Description
- SUPERSOFT™ T-TUBE 1.14MM ID X 8MM LENGTH SILICONE 5 PACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505012621 FDA UDI
- 510(k) Number
- K830228 FDA UDI
- FDA Product Code
- ETD FDA UDI
- GMDN Term
- Tympanostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tympanostomy tube
Supersoft™ T-Tube by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tympanostomy tube.
- Sheehy — MEDTRONIC XOMED, INC. · Class II
- NeoZoline — ADEPT MEDICAL LIMITED · Class II
- NeoZoline — ADEPT MEDICAL LIMITED · Class II
- NeoZoline — JEDMED Instrument Company · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Reuter Bobbin — MEDTRONIC XOMED, INC. · Class II
- NeoZoline — JEDMED Instrument Company · Class II
- Goode T-Tube® — MEDTRONIC XOMED, INC. · Class II
Cleared under the same submission
K830228 also covers:
- POPE VENT TUBE — Grace Medical, Inc.
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
- Summit Medical — Summit Medical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Grace Medical, Inc.
Sources (1)
- FDA UDI bc2e4fa1-e552-4b0e-8027-4f92a45d064a 35 fields · synced May 30, 2026