Identity
- Trade Name
- Symmetry ® EUDAMEDSymmetry Karlin™ FDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Curettes EUDAMEDKarlin Curette, Microdiscectomy Cervical, Forward Straight, Size 00, 8 1/2 in FDA UDI
- Model / Reference
- 46-3152 EUDAMEDFDA UDI
- Description
- Karlin Curette, Microdiscectomy Cervical, Forward Straight, Size 00, 8 1/2 in FDA UDI
Identifiers
- Catalog Number
- 46-3152 FDA UDI
- Primary DI / UDI-DI
- 00887482014660 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132CuretteHJ EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
- Length — 8.5 Inch FDA UDI
Category: Bone curette, reusable
Symmetry Karlin™ by Symmetry Surgical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone curette, reusable.
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- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Volkmann Bone Curette Oval - Fig. 00 17 cm - 6 3/4" Scoop Size 4.4 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · 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 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 4b62893c-31d9-4ce5-86d2-17da6a736eca 36 fields · synced Jul 11, 2026
- EUDAMED 39e9be41-cea5-4a95-9e5b-30d19a66b894 61 fields · synced Jul 11, 2026