Identity
- Trade Name
- TECOFLEX FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Device Name
- 6.0FR (2mm) X 22 cm LUBRI-FLEX OPEN TIP URETERAL STENT FDA UDI
- Model / Reference
- 5556022 FDA UDI
- Description
- 6.0FR (2mm) X 22 cm LUBRI-FLEX OPEN TIP URETERAL STENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925003125 FDA UDI
- 510(k) Number
- K905289 FDA UDI
- FDA Product Code
- FAD FDA UDI
- GMDN Term
- Polymeric ureteral stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Category: Polymeric ureteral stent
Tecoflex by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric ureteral stent.
- Polaris™ Loop — Boston Scientific · Class II
- Percuflex™ Plus — Boston Scientific · Class II
- Percuflex™ Plus — Boston Scientific · Class II
- Polaris™ Ultra — Boston Scientific · Class II
- Q UROLOGICAL PERSISTENT AGUAMEDICINA — Q Urological Corporation · Class II
- Universa — COOK INCORPORATED · Class II
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Cleared under the same submission
K905289 also covers:
- LUBRI-FLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
- TECOFLEX — Gyrus Acmi, Inc.
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI df6bf60b-3c99-436c-83d1-7dc4bd1a48b4 34 fields · synced Jun 6, 2026