Identity
- Trade Name
- Disposable Circular Staplers FDA UDI
- Generic Name
- Intraluminal circular stapler, single-use FDA UDI
- Model / Reference
- DCS A-27 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480501276 FDA UDI
- 510(k) Number
- K131511 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Intraluminal circular stapler, single-use
Disposable Circular Staplers by Sinolinks Medical Innovation Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intraluminal circular stapler, single-use.
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- EEA — Covidien LP · Class II
- EEA — Covidien LP · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Cleared under the same submission
K131511 also covers:
- Disposable Endoscopic Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
- Disposable Linear Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Sinolinks Medical Innovation Co., Ltd.
Sources (2)
- FDA UDI e25603d5-cf95-47d6-a332-001ac95d946f 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026