SCANLAN® Minimally-Invasive Instrumentation
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SCANLAN® Minimally-Invasive Instrumentation FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- SCANLAN® Thoracoscopic DeBakey Forceps EUDAMEDThor DeBakey Fcp, axial design, RH, 2.5 mm tips,w/ ratchet, 14-1/4"/36.5cm FDA UDI
- Model / Reference
- 9009-523 EUDAMEDFDA UDI
- Description
- Thor DeBakey Fcp, axial design, RH, 2.5 mm tips,w/ ratchet, 14-1/4"/36.5cm FDA UDI
Identifiers
- Catalog Number
- 9009-523 FDA UDI
- Primary DI / UDI-DI
- 00846159016598 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159016598 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical soft-tissue manipulation forceps, tweezers-like, reusable
SCANLAN® Minimally-Invasive Instrumentation by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 846da1dc-a411-40aa-a7e9-17c228636fef 35 fields · synced Jul 24, 2026
- EUDAMED b5924ab7-4d0d-484e-8c9a-ea925a7fad5f 61 fields · synced Jul 24, 2026