Identity
- Trade Name
- Single-use Ureteral Access Sheath FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Model / Reference
- UA-S1803 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197483437 FDA UDI
- 510(k) Number
- K250785 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ureteral introduction sheath
Single-use Ureteral Access Sheath by Hunan Vathin Medical Instrument 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
- Praveza ® Ureteral Access Sheath — Blue Neem Medical Devices Private Limited · Class IIa
Cleared under the same submission
K250785 also covers:
- Single-use Ureteral Access Sheath — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
- Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Flexible Ureteroscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument 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 |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd
Sources (1)
- FDA UDI 89eb7918-be8f-412b-b87e-6a3d7264f95f 33 fields · synced Jun 8, 2026