Identity
- Trade Name
- AMT Introducer FDA UDI
- Generic Name
- Gastrostomy procedure kit FDA UDI
- Device Name
- Introducer (Pouched) FDA UDI
- Model / Reference
- E4-5000 FDA UDI
- Description
- Introducer (Pouched) FDA UDI
Identifiers
- Catalog Number
- E4-5000, 4-5000 FDA UDI
- Primary DI / UDI-DI
- 00842071106881 FDA UDI
- 510(k) Number
- K042300 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrostomy procedure kit 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
No
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: Gastrostomy procedure kit
AMT Introducer by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy procedure kit.
- Fidmi Low Profile Percutaneous Endoscopic Measuring Kit — Fidmi Medical, Ltd.
- AMT Stiffener for Initial Placement — Applied Medical Technology, Inc. · Class II
- AMT Initial Placement Dilator Set — Applied Medical Technology, Inc. · Class II
- AMT Initial Placement Kit — Applied Medical Technology, Inc. · Class II
- AMT Initial Placement Dilator Set — Applied Medical Technology, Inc. · Class II
- AMT PEG-Assist — Applied Medical Technology, Inc. · Class II
- AMT Initial Placement Kit — Applied Medical Technology, Inc. · Class II
Cleared under the same submission
K042300 also covers:
- AMT Introducer — Applied Medical Technology, Inc.
- AMT Stiffener for Initial Placement — Applied Medical Technology, Inc.
- AMT Stiffener for Initial Placement — Applied Medical Technology, Inc.
- AMT Stiffener for Initial Placement — Applied Medical Technology, Inc.
- AMT Stiffener for Initial Placement — 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 1f7da48b-039e-486f-9746-5d49cb3fd3be 36 fields · synced Jun 9, 2026