Identity
- Trade Name
- Tarkington FDA UDI
- Generic Name
- Polymeric urethral stent, short-term FDA UDI
- Device Name
- Tarkington Urethral Stent Set FDA UDI
- Model / Reference
- G15614 FDA UDI
- Description
- Tarkington Urethral Stent Set FDA UDI
Identifiers
- Catalog Number
- 032408 FDA UDI
- Primary DI / UDI-DI
- 00827002156142 FDA UDI
- FDA Product Code
- KOD 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
Tarkington by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric urethral stent, short-term.
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- Surveyor Urethral Measurement Device — SRS Medical Systems, Inc. · Class III
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
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
- Cook Incorporated
Sources (1)
- FDA UDI ada98d6a-9c09-44e7-9a23-6982645e487d 36 fields · synced Jun 8, 2026