Identity
- Trade Name
- SCANLAN® Retractor FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- SCANLAN® Pediatric Titanium Retractor EUDAMEDPediatric Titanium Retractor FDA UDI
- Model / Reference
- 8008-43-1 EUDAMEDFDA UDI
- Description
- Pediatric Titanium Retractor FDA UDI
Identifiers
- Catalog Number
- 8008-43-1 FDA UDI
- Primary DI / UDI-DI
- 00846159023831 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159023831 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Self-retaining surgical retractor, 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
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: Self-retaining surgical retractor, reusable
SCANLAN® Retractor 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 Self-retaining surgical retractor, reusable.
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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 c8d2869d-0f54-400e-a577-d6a2448067d0 35 fields · synced Jun 19, 2026
- EUDAMED 864bba64-11a5-440b-a0dc-055829368272 61 fields · synced Jun 19, 2026