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Disposable Linear Cutter Staplers and Reloads
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Disposable Linear Cutter Staplers and Reloads FDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Model / Reference
- DCR B-80B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480576151 FDA UDI
- 510(k) Number
- K131511 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Open-surgery manual linear cutting 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: Open-surgery manual linear cutting stapler, single-use
Disposable Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
- GIA — Covidien LP · Class II
- ZHY series of disposable auto linear stapler and cartridge — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- Disposable Circumcision Staplers — Sinolinks Medical Innovation, Inc. · Class IIa
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Cartridge for Disposable Linear Cutter — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Endoscopic Linear Cutter Staplers and Cartridges — ChangZhou 3R Medical Device Technology Co.,Ltd · Class IIb
Cleared under the same submission
K131511 also covers:
- Disposable Circular Staplers — Sinolinks Medical Innovation Co., Ltd.
- 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 Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 ed45b6ae-c4e9-4b9a-b05c-e1788c3448db 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026