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Klockner
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20 07 17Model Basic UDI
by Soadco, S.l.
Identity
- Trade Name
- SURGICAL GUIDE REAMER [Ø4.2MM] EUDAMEDKLOCKNER FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- REAMER SPLINT [Ø4.2 MM] FDA UDI
- Model / Reference
- 20 07 17 EUDAMEDFDA UDIBasic UDI EUDAMED
- Description
- REAMER SPLINT [Ø4.2 MM] FDA UDI
Identifiers
- Catalog Number
- 20 07 17 FDA UDI
- Primary DI / UDI-DI
- 08435451662019 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354516TF21QG EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain 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
No
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
Category: Surgical screwdriver, reusable
Klockner by Soadco, S.l. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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
- Soadco, S.l.
Sources (2)
- FDA UDI d7ebfbaa-4f87-4392-931c-5f42923c8c32 35 fields · synced Jun 18, 2026
- EUDAMED 8d64ef84-12d4-42d1-968e-8fa4f851a15e 61 fields · synced Jun 18, 2026