Identity
- Trade Name
- Symmetry ® EUDAMEDSymmetry Sewall FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Hand Retractors EUDAMEDSymmetry® Retractor, Sewall Orbital, 11.0 mm x 50.0 mm Blade, 6 1/2 in FDA UDI
- Model / Reference
- 63-4005 EUDAMEDFDA UDI
- Description
- Symmetry® Retractor, Sewall Orbital, 11.0 mm x 50.0 mm Blade, 6 1/2 in FDA UDI
Identifiers
- Catalog Number
- 63-4005 FDA UDI
- Primary DI / UDI-DI
- 00887482118221 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132HandRetractorHC EUDAMED
- FDA Product Code
- HNI FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 11 Millimeter FDA UDIDepth — 50 Millimeter FDA UDILength — 6.5 Inch FDA UDI
Category: Hand-held surgical retractor, reusable
Symmetry Sewall by Symmetry Surgical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Surgical Inc.
Sources (2)
- FDA UDI 9e175dcc-e7d4-4b21-80a8-0a0d98c353a1 36 fields · synced Jul 9, 2026
- EUDAMED 65608f77-510a-4a8b-8cda-677776a4861a 61 fields · synced Jul 9, 2026