Identity
- Trade Name
- Porges Coloplast FDA UDI
- Generic Name
- General-purpose non-vascular guidewire FDA UDI
- Device Name
- ORCHESTRA® Hydrophilic guidewire, angled, stiff, 3 cm flexible tip FDA UDI
- Model / Reference
- AECE35 FDA UDI
- Description
- ORCHESTRA® Hydrophilic guidewire, angled, stiff, 3 cm flexible tip FDA UDI
Identifiers
- Catalog Number
- AECE35 FDA UDI
- Primary DI / UDI-DI
- 00884450143346 FDA UDI
- FDA Product Code
- OCY FDA UDI
- GMDN Term
- General-purpose non-vascular guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
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 — 0.035 Inch FDA UDI
Category: General-purpose non-vascular guidewire
Porges Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose non-vascular guidewire.
- Jagwire — Boston Scientific · Class II
- GUIDE WIRE M — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · Class II
- PTFE Coated Urological Guidewire — Lake Region Medical · Class I
- RX Cholangiogram Kit — Boston Scientific · Class II
- PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITED · Class I
- GLIDEWIRE — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · Class II
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
- Coloplast A/S
Sources (1)
- FDA UDI 8840c4ee-a615-448b-a3e3-c2ba978f11cc 37 fields · synced Jun 1, 2026