Identity
- Trade Name
- Silhouette® Peel-Away® EUDAMEDSilhouette FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Device Name
- Silhouette® Transitionless Peel-Away® Introducer EUDAMEDSilhouette, Transitionless Peel-Away, Introducer FDA UDI
- Model / Reference
- PLVTW-24.0-38-30 EUDAMEDG08782 FDA UDI
- Description
- Silhouette, Transitionless Peel-Away, Introducer FDA UDI
Identifiers
- Catalog Number
- PLVTW-24.0-38-30 FDA UDI
- Primary DI / UDI-DI
- 00827002087828 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002087828 EUDAMED
- FDA Product Code
- KGZ FDA UDI
- EMDN Code
- C0503 CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY EUDAMED
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Non-vascular catheter introduction set
Silhouette by Cook Incorporated — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI f65798ef-0e5f-48d5-b5d0-bcaa79a29445 36 fields · synced Jun 14, 2026
- EUDAMED ae2f928d-0a14-4b43-b8ea-f3ac2567e50c 61 fields · synced Jun 11, 2026