Identity
- Trade Name
- Koyle FDA UDI
- Generic Name
- Polymeric urethral stent, short-term FDA UDI
- Device Name
- Koyle Diaper Stent FDA UDI
- Model / Reference
- G18827 FDA UDI
- Description
- Koyle Diaper Stent FDA UDI
Identifiers
- Catalog Number
- KDSCF-060050-FL26-IM FDA UDI
- Primary DI / UDI-DI
- 00827002188273 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Polymeric urethral stent, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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: Polymeric urethral stent, short-term
Koyle by Cook Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Polymeric urethral stent, short-term.
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- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI cccadc97-b78a-424c-b34a-73feaab7c66a 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026