Identity
- Trade Name
- StecoGuide EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Planning and drill sleeves EUDAMEDCeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.4/L5.0 -> For further information visit steco.de FDA UDI
- Model / Reference
- M.27.06.D240 EUDAMEDFDA UDI
- Description
- CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.4/L5.0 -> For further information visit steco.de FDA UDI
Identifiers
- Catalog Number
- M.27.06.D240 FDA UDI
- Primary DI / UDI-DI
- +ESTOM2706D240 EUDAMEDESTOM2706D2400 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
Yes
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
Yes
FDA UDI
StecoGuide by steco-System-Technik GmbH & Co KG — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 13aa8571-0656-4a15-a06b-85a36ca49ffe 35 fields · synced Oct 7, 2026
- EUDAMED 29cc7615-3b1c-4cb5-8c32-29e5fdba0d17 61 fields · synced Jul 19, 2026