Identity
- Trade Name
- Single Use Circular Stapler FDA UDI
- Generic Name
- Intraluminal circular stapler, single-use FDA UDI
- Model / Reference
- CSC26 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946912217034 FDA UDI
- 510(k) Number
- K162707 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Intraluminal circular stapler, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 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
No
FDA UDI
Category: Intraluminal circular stapler, single-use
Single Use Circular Stapler by Golden Stapler Surgical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162707 also covers:
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd
- Single Use Circular Stapler — Golden Stapler Surgical 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
- Golden Stapler Surgical Co., Ltd
Sources (1)
- FDA UDI 21ce1b78-b4ca-40a2-a656-40741cdf8299 33 fields · synced Jun 6, 2026