Thora Mayo Scs 10 mm w/wide blades
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Thora Mayo Scs 10 mm w/wide blades FDA UDI
- Generic Name
- Rigid endoscopic scissors, reusable FDA UDI
- Device Name
- SCANLAN® Thoracoscopic Metz Scissors EUDAMEDThoracoscopic Metz Scissors, 10mm, Wide Blades FDA UDI
- Model / Reference
- 9909-911SC EUDAMEDFDA UDI
- Description
- Thoracoscopic Metz Scissors, 10mm, Wide Blades FDA UDI
Identifiers
- Catalog Number
- 9909-911SC FDA UDI
- Primary DI / UDI-DI
- 00846159025385 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159025385 EUDAMED
- 510(k) Number
- K945474 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L01040402 VASCULAR SCISSORS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscopic scissors, 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
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Rigid endoscopic scissors, reusable
Thora Mayo Scs 10 mm w/wide blades by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic scissors, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
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- ELMED — ELMED INCORPORATED · Class II
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- Olympus — Olympus Winter & Ibe GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
Cleared under the same submission
K945474 also covers:
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
- SCANLAN® — SCANLAN INTERNATIONAL INC
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 0604feeb-1704-4112-936b-71164daf37e6 36 fields · synced Jul 10, 2026
- EUDAMED ceb849c3-3630-40d4-a35b-21d030101919 61 fields · synced Jul 10, 2026