Identity
- Trade Name
- Amplatz FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Device Name
- Amplatz Radiopaque TFE Sheath Use with 30 FR Amplatz dilator FDA UDI
- Model / Reference
- G17971 FDA UDI
- Description
- Amplatz Radiopaque TFE Sheath Use with 30 FR Amplatz dilator FDA UDI
Identifiers
- Catalog Number
- VS-300020-ARI FDA UDI
- Primary DI / UDI-DI
- 00827002179714 FDA UDI
- FDA Product Code
- KOE FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5520 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
Yes
FDA UDI
Category: Non-vascular catheter introduction set
Amplatz by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-vascular catheter introduction set.
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- Aspire Introducer Needle — ASPIRE BARIATRICS, INC. · Class II
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- Inrad — Inrad · Class II
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle — FLEXBAR MACHINE CORP. · Class I
- MAK-NV™ — Merit Medical Systems, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 8d75759e-fa26-4014-a859-927ea3acc1cd 36 fields · synced Jun 8, 2026