Identity
- Trade Name
- Symmetry ® EUDAMEDSymmetry Stille-Luer FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Rongeurs EUDAMEDSymmetry® Rongeur, Bone Double/A, Straight, 9 in FDA UDI
- Model / Reference
- 31-3024 EUDAMEDFDA UDI
- Description
- Symmetry® Rongeur, Bone Double/A, Straight, 9 in FDA UDI
Identifiers
- Catalog Number
- 31-3024 FDA UDI
- Primary DI / UDI-DI
- 00887482068885 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132RongeurLP EUDAMED
- 510(k) Number
- K081651 FDA UDI
- FDA Product Code
- HAE FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical gouge 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
No
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
- Length — 9 Inch FDA UDI
Category: Surgical gouge
Symmetry Stille-Luer by Symmetry Surgical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gouge.
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Sklar® — Sklar Corporation · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Life Instruments — Life Instrument Corporation · Class I
Cleared under the same submission
K081651 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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 f21aba26-3104-465e-9c4d-3fc0970a82b4 37 fields · synced Jun 19, 2026
- EUDAMED 2ce6853e-3f7f-44fa-a90a-32d56eee8357 61 fields · synced Jun 19, 2026