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Disposable Endoscopic Linear Cutter Staplers and Reloads
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DER B 60T
Identity
- Trade Name
- Disposable Endoscopic Linear Cutter Staplers and Reloads EUDAMEDFDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Disposable endoscopic linear cutter staplers and reloads EUDAMED
- Model / Reference
- DER B 60T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480589366 EUDAMEDFDA UDI
- Basic UDI-DI
- 69464805DEC-A/BJ5 EUDAMED
- Direct Marketing DI
- 06946480589366 EUDAMED
- 510(k) Number
- K131511 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020301040101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR THORACOSCOPY EUDAMED
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Disposable Endoscopic Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69464805DEC-A/BJ5 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3dc57dcf-e7d6-4d72-86e4-cabed5bc74a1 61 fields · synced Oct 6, 2026
- FDA UDI f11cf57e-c195-400a-a6df-b236ce8a6f68 33 fields · synced May 30, 2026