Identity
- Trade Name
- SCANLAN® M.D. Retractor Arm FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- SCANLAN® M.D. Titanium Retractor Arm EUDAMEDSCANLAN® M.D. Retractor Arm Size 1 Right FDA UDI
- Model / Reference
- 8008-931R EUDAMEDFDA UDI
- Description
- SCANLAN® M.D. Retractor Arm Size 1 Right FDA UDI
Identifiers
- Catalog Number
- 8008-931R FDA UDI
- Primary DI / UDI-DI
- 00846159034509 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159034509 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, reusable 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
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: Surgical retractor/retraction system blade, reusable
SCANLAN® M.D. Retractor Arm 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 b03ed06d-cde0-4c51-b3e0-04b5dfc8079f 35 fields · synced Jun 19, 2026
- EUDAMED b7513a81-f664-48fa-af78-53901ea0a3ec 61 fields · synced Jun 19, 2026