← Back to catalogue
SCANLAN® Minimally-Invasive Instrumentation
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3003-432N
Identity
- Trade Name
- SCANLAN® Minimally-Invasive Instrumentation FDA UDI
- Generic Name
- Lung spatula FDA UDI
- Device Name
- SCANLAN® Periosteal Elevator EUDAMEDThorascopic Periosteal Elevator FDA UDI
- Model / Reference
- 3003-432N EUDAMED9009-823-14 FDA UDI
- Description
- Thorascopic Periosteal Elevator FDA UDI
Identifiers
- Catalog Number
- 9009-823-14 FDA UDI
- Primary DI / UDI-DI
- 00846159035186 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159035186 EUDAMED
- FDA Product Code
- HTE FDA UDI
- EMDN Code
- L031102 EXPLORATION PROBES, REUSABLE EUDAMED
- GMDN Term
- Lung spatula 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
No
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: Lung spatula
SCANLAN® Minimally-Invasive Instrumentation by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lung spatula.
- Sklar — Sklar Corporation · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MICTEC PLEURAELEVATORIUM — SONTEC INSTRUMENTS, INC. · Class II
- UNITRAC — AESCULAP, INC. · Class I
- MICTEC PLEURA ABRADER — SONTEC INSTRUMENTS, INC. · Class II
- MICTEC PLEURA ABRADER — SONTEC INSTRUMENTS, INC. · Class II
- Sklar — Sklar Corporation · Class I
- V. Mueller — STERIS CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 7fc53ba0-19b0-4bea-897e-1917eab2149c 35 fields · synced Jul 21, 2026
- EUDAMED 7ae19181-9e89-4e62-86d1-d057821e83c9 61 fields · synced Jul 21, 2026