Identity
- Trade Name
- OSSEOUS Salivary by Pass Tube FDA UDI
- Generic Name
- Polymeric oesophageal stent, non-bioabsorbable FDA UDI
- Device Name
- "Salivary by-pass Tube directs saliva which discharges from neck wound after surgery into the distal esophagus and to facilitate the management of fistula resulting from a variety of causes including advanced malignancy, surgery, radiation, trauma and caustic ingestion. " FDA UDI
- Model / Reference
- E31412C FDA UDI
- Description
- "Salivary by-pass Tube directs saliva which discharges from neck wound after surgery into the distal esophagus and to facilitate the management of fistula resulting from a variety of causes including advanced malignancy, surgery, radiation, trauma and caustic ingestion. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906039312102 FDA UDI
- FDA Product Code
- KCF FDA UDI
- GMDN Term
- Polymeric oesophageal stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 24 Millimeter FDA UDILength — 188 Millimeter FDA UDI
Category: Polymeric oesophageal stent, non-bioabsorbable
OSSEOUS Salivary by Pass Tube by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric oesophageal stent, non-bioabsorbable.
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Esophageal Tube — Boston Medical Products, Inc. · Class I
- Montgomery® Salivary Bypass Tube — Boston Medical Products, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Eon Meditech Private Limited
Sources (1)
- FDA UDI 7dca8292-1f5f-4725-ae92-ac5c3336436f 35 fields · synced May 30, 2026