FDA.reportPublic FDA data

StecoGuide

Primary DI
ESTOM2703E2000
Brand
StecoGuide
Company
steco-System-Technik GmbH & Co KG
Model
M.27.03.E200
Catalog number
M.27.03.E200
Device description
Sleeve pressing tool ø 2.00 for M.27.03.D200
Published
2018-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2703E2002PackageHIBCC1In Commercial Distribution
ESTOM2703E2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49405577810info@steco.de

Regulatory Flags#

DUNS number
389566209
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H0005KX40StecoTitanmagnetics®H.00.05.KX4H.00.05.KX42026-05-08
H0005TX40StecoTitanmagnetics®H.00.05.TX4H.00.05.TX42026-05-08
ESTOI0107K5000StecoTitanmagnetics®I.01.07.K500I.01.07.K5002025-10-14
ESTOI0206X5200StecoTitanmagnetics®I.02.06.X520I.02.06.X5202025-10-08
ESTOI0207X3700StecoTitanmagnetics®I.02.07.X370I.02.07.X3702025-10-08
ESTOM2701D116L40StecoGuideM.27.01.D116L4M.27.01.D116L42025-10-08
ESTOM2701D205L50StecoGuideM.27.01.D205L5M.27.01.D205L52025-10-08
ESTOM2701D210L50StecoGuideM.27.01.D210L5M.27.01.D210L52025-10-08
ESTOV0003X2600StecoTitanmagnetics®V.00.03.X260V.00.03.X2602025-10-08
ESTOV0008W2650StecoTitanmagnetics®V.00.08.W265V.00.08.W2652025-10-08
ESTOI3401K2500StecoTitanmagnetics®I.34.01.K250I.34.01.K2502025-05-22
ESTOI3401K4500StecoTitanmagnetics®I.34.01.K450I.34.01.K4502025-05-22
ESTOI3401T4000StecoTitanmagnetics®I.34.01.T400I.34.01.T4002025-05-22
ESTOI3401X2600StecoTitanmagnetics®I.34.01.X260I.34.01.X2602025-05-22
ESTOI3401X4500StecoTitanmagnetics®I.34.01.X450I.34.01.X4502025-05-22
ESTOI3401X6000StecoTitanmagnetics®I.34.01.X600I.34.01.X6002025-05-22
ESTOI3401X8000StecoTitanmagnetics®I.34.01.X800I.34.01.X8002025-05-22
ESTOI3401Z4500StecoTitanmagnetics®I.34.01.Z450I.34.01.Z4502025-05-22
ESTOI3402K2000StecoTitanmagnetics®I.34.02.K200I.34.02.K2002025-05-22
ESTOI3402T3000StecoTitanmagnetics®I.34.02.T300I.34.02.T3002025-05-22

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08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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