Identity
- Trade Name
- StecoGuide EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Planning and drill sleeves EUDAMEDTitanium outer sleeve D4.0/d3.5/L6.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
- Model / Reference
- M.27.02.D350 EUDAMEDFDA UDI
- Description
- Titanium outer sleeve D4.0/d3.5/L6.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
Identifiers
- Catalog Number
- M.27.02.D350 FDA UDI
- Primary DI / UDI-DI
- +ESTOM2702D350 EUDAMEDESTOM2702D3500 FDA UDI
- Basic UDI-DI
- ++ESTOM27LB EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
StecoGuide by steco-System-Technik GmbH & Co KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- steco-System-Technik GmbH & Co KG
Sources (2)
- FDA UDI c7cc0ba5-06c6-4336-9378-86e5bd64ebc5 35 fields · synced Oct 7, 2026
- EUDAMED 2c303e33-06a6-4f9c-bec8-3d13f572043a 61 fields · synced Jul 9, 2026