Identity
- Trade Name
- ClearPetra FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- ClearPetra Ureteral Access Sheath 10Fr x 50cm FDA UDI
- Model / Reference
- 90111050 FDA UDI
- Description
- ClearPetra Ureteral Access Sheath 10Fr x 50cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881196263 FDA UDI
- 510(k) Number
- K161110 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Ureteral introduction sheath 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
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: Ureteral introduction sheath
ClearPetra by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
Cleared under the same submission
K161110 also covers:
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
- ClearPetra — Well Lead Medical Co., Ltd
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI f568429c-fb2d-4d1c-9994-4891f9c97523 34 fields · synced May 30, 2026