Identity
- Trade Name
- Well Lead Extraction Bag FDA UDI
- Generic Name
- Surgical tissue/fluid collection bag FDA UDI
- Device Name
- Type E 2500ml FDA UDI
- Model / Reference
- O02A052510 FDA UDI
- Description
- Type E 2500ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881166495 FDA UDI
- 510(k) Number
- K160801 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical tissue/fluid collection bag 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: Surgical tissue/fluid collection bag
Well Lead Extraction Bag by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160801 also covers:
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — Well Lead Medical Co., Ltd
- Well Lead Extraction Bag — 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 828f14ba-0b60-4d54-9580-f518439dbcdd 34 fields · synced May 31, 2026