Identity
- Trade Name
- SCANLAN® Titanium Clamp FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
- Device Name
- SCANLAN® Titanium Coarctation Clamp EUDAMEDSCANLAN® Titanium Debakey Clamp FDA UDI
- Model / Reference
- 3003-619 EUDAMEDFDA UDI
- Description
- SCANLAN® Titanium Debakey Clamp FDA UDI
Identifiers
- Catalog Number
- 3003-619 FDA UDI
- Primary DI / UDI-DI
- 00846159033809 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159033809 EUDAMED
- FDA Product Code
- GDJ FDA UDI
- EMDN Code
- L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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, scissors-like, reusable
SCANLAN® Titanium Clamp by Scanlan International Inc — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI b46c9153-2530-47ec-9cbe-30aad7ccfc81 35 fields · synced Aug 3, 2026
- EUDAMED 61b0ee8e-e503-4d4b-a8e4-0feae7e864a3 61 fields · synced Aug 3, 2026