Identity
- Trade Name
- Symmetry ® EUDAMEDSymmetry LEKSELL FDA UDI
- Generic Name
- Rib rongeur FDA UDI
- Device Name
- Rongeurs EUDAMEDSymmetry® Rongeur; Leksell Laminectomy; Regular; Narrow FDA UDI
- Model / Reference
- 53-1127 EUDAMEDFDA UDI
- Description
- Symmetry® Rongeur; Leksell Laminectomy; Regular; Narrow FDA UDI
Identifiers
- Catalog Number
- 53-1127 FDA UDI
- Primary DI / UDI-DI
- 00887482021811 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132RongeurLP EUDAMED
- FDA Product Code
- HAE FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Rib rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4840 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rib rongeur
Symmetry LEKSELL by Symmetry Surgical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rib rongeur.
- IVD Rongeur — Koros USA, Inc. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- IVD Rongeur — Koros USA, Inc. · Class I
- Raptor Rongeur — Koros USA, Inc. · Class I
- Axis Rongeur — Koros USA, Inc. · Class I
- OP Rongeur — Koros USA, Inc. · Class I
- IVD Rongeur — Koros USA, Inc. · Class I
- OP Rongeur — Koros USA, Inc. · Class I
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Surgical Inc.
Sources (2)
- FDA UDI f684ac05-60f9-4e3a-8a93-5b3e079be862 35 fields · synced Jun 18, 2026
- EUDAMED b9b1e63d-1011-4d12-8ed9-090ef332c67b 61 fields · synced Jun 18, 2026