Well Lead Extraction Bag
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Wellead Extraction Bag EUDAMEDWell Lead Extraction Bag FDA UDI
- Generic Name
- Surgical tissue/fluid collection bag FDA UDI
- Device Name
- Extraction Bag EUDAMEDType B 800ml FDA UDI
- Model / Reference
- O02A020810 EUDAMEDFDA UDIType B EUDAMED
- Description
- Type B 800ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881133770 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FO02A02HX EUDAMED
- 510(k) Number
- K160801 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Surgical tissue/fluid collection bag FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Surgical tissue/fluid collection bag
Well Lead Extraction Bag by Well Lead Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 0e3d6605-3cd8-47c2-bc79-c4bcc21df016 34 fields · synced Jun 18, 2026
- EUDAMED bf6696c0-0e52-490e-ac80-67a3d9ec0474 61 fields · synced Jun 18, 2026