Identity
- Trade Name
- SCANLAN® Rongeur FDA UDI
- Generic Name
- Rib rongeur FDA UDI
- Device Name
- SCANLAN® Bending and Blade Tool for Nitinol instruments EUDAMEDSCANLAN® MEMORY Blade and blade tool FDA UDI
- Model / Reference
- 8008-405 EUDAMEDFDA UDI
- Description
- SCANLAN® MEMORY Blade and blade tool FDA UDI
Identifiers
- Catalog Number
- 8008-405 FDA UDI
- Primary DI / UDI-DI
- 00846159019834 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159019834 EUDAMED
- FDA Product Code
- HTX FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Rib rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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: Rib rongeur
SCANLAN® Rongeur 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 Rib rongeur.
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- IVD Rongeur — Koros USA, Inc. · Class I
- OP Rongeur — Koros USA, Inc. · Class I
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 fe642918-24d0-4c5d-bb8b-eaaf92e5140e 35 fields · synced Jun 18, 2026
- EUDAMED f501ec71-0d85-4cb0-abcc-6f55ba6b72c6 61 fields · synced Jun 18, 2026