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Disposable Linear Staplers and Reloads
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DLS B-60B
Identity
- Trade Name
- Disposable Linear Staplers and Reloads EUDAMEDFDA UDI
- Generic Name
- Open-surgery manual linear stapler, single-use FDA UDI
- Device Name
- Disposable Linear Staplers and Reloads EUDAMED
- Model / Reference
- DLS B-60B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946480503638 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06946480503638 EUDAMED
- 510(k) Number
- K131511 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery manual linear 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 Linear Staplers and Reloads by Sinolinks Medical Innovation, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06946480503638 | 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 0f53937d-e646-4d7a-b819-a6216cae8483 61 fields · synced Oct 6, 2026
- FDA UDI b6e5097b-6962-419d-b257-5c7fc3724c4f 33 fields · synced May 30, 2026