Identity
- Trade Name
- Scanlan® VASCU-STATT® Applier FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- SCANLAN® VASCU‑STATT® appliers EUDAMEDVASCU-STATT Applier, Curved, stainless steel 8-1/2"/21.5 cm FDA UDI
- Model / Reference
- 1001-506A EUDAMEDFDA UDI
- Description
- VASCU-STATT Applier, Curved, stainless steel 8-1/2"/21.5 cm FDA UDI
Identifiers
- Catalog Number
- 1001-506A FDA UDI
- Primary DI / UDI-DI
- 00846159014990 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159014990 EUDAMED
- FDA Product Code
- GDJ FDA UDI
- EMDN Code
- L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery ligation clip applier 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery ligation clip applier
Scanlan® VASCU-STATT® Applier by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery ligation clip applier.
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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 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 60a2a0ec-0f1d-4e5f-80ef-e03de1777a12 35 fields · synced Jul 31, 2026
- EUDAMED f99634d3-6807-489a-ac52-8f23b5e1eb24 61 fields · synced Jul 31, 2026