Identity
- Trade Name
- AMT Guidewire FDA UDI
- Generic Name
- Gastrojejunostomy tube FDA UDI
- Device Name
- Guidewire (.038"Dia x180cm, pouched) FDA UDI
- Model / Reference
- E4-GW-5 FDA UDI
- Description
- Guidewire (.038"Dia x180cm, pouched) FDA UDI
Identifiers
- Catalog Number
- E4-GW-5, 4-GW-5 FDA UDI
- Primary DI / UDI-DI
- 00842071106959 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrojejunostomy 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
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: Gastro-urological guidewire, single-useGastrojejunostomy tube
AMT Guidewire by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrojejunostomy tube.
- EndoVive Jejunal Feeding Tube — Boston Scientific · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- Traditional G-Jet® — Applied Medical Technology, Inc. · Class II
- Micro G-Jet® — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
Cleared under the same submission
K110804 also covers:
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Mini Extension Set — Applied Medical Technology, Inc.
- AMT Mini ONE® Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
K123716 also covers:
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Mini Extension Set — Applied Medical Technology, Inc.
- AMT Mini ONE® Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
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
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI fa23c015-3bb3-4914-be3c-877dedd337a8 37 fields · synced Jun 9, 2026