Identity
- Trade Name
- AMPLATZ GOOSE NECK FDA UDI
- Generic Name
- Intravascular extraction catheter-snare FDA UDI
- Device Name
- Snare Kit FDA UDI
- Model / Reference
- GN3000 FDA UDI
- Description
- Snare Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684004128 FDA UDI
- 510(k) Number
- K972511 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Intravascular extraction catheter-snare FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Dimensions & Sizes
- Size
- Outer Diameter — 0.052 Inch FDA UDILength — 120 Centimeter FDA UDIOuter Diameter — 30 Millimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Intravascular extraction catheter-snare
Amplatz Goose Neck by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular extraction catheter-snare.
- TourniKwik™ — MEDTRONIC, INC. · Class I
- ONE Snare® — Merit Medical Systems, Inc. · Class II
- NCircle — COOK INCORPORATED · Class I
- EN Snare® — Merit Medical Systems, Inc. · Class II
- ONO Retrieval Device — Onocor LLC · Class II
- Amplatz Goose Neck™ — MEDTRONIC, INC. · Class II
- Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, Inc. · Class II
- Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, Inc. · Class II
Cleared under the same submission
K972511 also covers:
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
- AMPLATZ GOOSE NECK — Covidien LP
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
- Covidien LP
Sources (1)
- FDA UDI 6ae4a162-2062-4094-b9ff-4483be0dc1a8 37 fields · synced May 30, 2026