SCANLAN® Minimally Invasive Instrumentation
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SCANLAN® Minimally Invasive Instrumentation FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- SCANLAN® Endoscopic Fine Needle Holder EUDAMEDEndoscopic Fine Needle Holder curved 5mm w/ratchet DD jaws 9-3/4"/24.8cm FDA UDI
- Model / Reference
- 9009-360N-12C EUDAMEDFDA UDI
- Description
- Endoscopic Fine Needle Holder curved 5mm w/ratchet DD jaws 9-3/4"/24.8cm FDA UDI
Identifiers
- Catalog Number
- 9009-360N-12C FDA UDI
- Primary DI / UDI-DI
- 00846159023053 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159023053 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 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: Suturing needle holder, reusable
SCANLAN® Minimally Invasive Instrumentation 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 abea157a-e7fe-49b0-8f84-9e58fa77f4ff 35 fields · synced Jun 19, 2026
- EUDAMED c7020d5b-eb7c-4b75-8310-ecae64062250 61 fields · synced Jun 19, 2026