Identity
- Trade Name
- Sovea™ FDA UDI
- Generic Name
- Gastrostomy tube FDA UDI
- Device Name
- Sovea™ Extension Set, Straight Connector, 12" FDA UDI
- Model / Reference
- ITG-23112 FDA UDI
- Description
- Sovea™ Extension Set, Straight Connector, 12" FDA UDI
Identifiers
- Catalog Number
- ITG-23112 FDA UDI
- Primary DI / UDI-DI
- 10850009501377 FDA UDI
- 510(k) Number
- K092418 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Gastrostomy tube
Sovea™ by Cutting Edge Hc Brands Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
Cleared under the same submission
K092418 also covers:
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS LLC
- Sovea™ — CUTTING EDGE HC BRANDS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cutting Edge Hc Brands Llc
Sources (1)
- FDA UDI 746e1223-3b6b-4c36-8737-2f02d9312bf5 37 fields · synced Jun 1, 2026