Identity
- Trade Name
- ZKSK FDA UDI
- Generic Name
- Polypectomy endoscopic ligator, single-use FDA UDI
- Device Name
- Disposable Ligation Device FDA UDI
- Model / Reference
- HE40-195-1 FDA UDI
- Description
- Disposable Ligation Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934415023320 FDA UDI
- FDA Product Code
- MND FDA UDI
- GMDN Term
- Polypectomy endoscopic ligator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polypectomy endoscopic ligator, single-use
Zksk by Beijing ZKSK Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polypectomy endoscopic ligator, single-use.
- Bioseal Inc. — BIOSEAL · Class II
- SINGLE USE LIGATING DEVICE — Olympus Medical Systems Corporation · Class II
- SINGLE USE LIGATING DEVICE — Olympus Medical Systems Corporation · Class II
- Bioseal Inc. — BIOSEAL · Class I
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
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
- Beijing ZKSK Technology Co., Ltd
Sources (1)
- FDA UDI fa471522-35c8-4b2a-ab7c-982bb86125a0 34 fields · synced May 30, 2026