FDA.report

StecoGuide

Primary DI
ESTOM2702D3500
Brand
StecoGuide
Company
steco-System-Technik GmbH & Co KG
Model
M.27.02.D350
Catalog number
M.27.02.D350
Device description
Titanium outer sleeve D4.0/d3.5/L6.0 for surgical guides/templates-> For further information visit steco.de
Published
2018-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M2702D3502PackageHIBCC10In Commercial Distribution
ESTOM2702D3500PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+49405577810info@steco.de

Regulatory Flags

DUNS number
389566209
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ESTOM0001T10500StecoTitanmagnetics®M.00.01.T1050M.00.01.T10502023-07-25
ESTOM0001X16000StecoTitanmagnetics®M.00.01.X1600M.00.01.X16002023-07-25
ESTOA0001X5550StecoTitanmagnetics®A.00.01.X555A.00.01.X5552023-07-24
ESTOH0004K10StecoTitanmagnetics®H.00.04.K1H.00.04.K12023-07-24
ESTOH0004K20StecoTitanmagnetics®H.00.04.K2H.00.04.K22023-07-24
ESTOH0004K30StecoTitanmagnetics®H.00.04.K3H.00.04.K32023-07-24
ESTOH0004K40StecoTitanmagnetics®H.00.04.K4H.00.04.K42023-07-24
ESTOH0004T10StecoTitanmagnetics®H.00.04.T1H.00.04.T12023-07-24
ESTOH0004T20StecoTitanmagnetics®H.00.04.T2H.00.04.T22023-07-24
ESTOH0004T30StecoTitanmagnetics®H.00.04.T3H.00.04.T32023-07-24
ESTOH0004T40StecoTitanmagnetics®H.00.04.T4H.00.04.T42023-07-24
ESTOH0004X10StecoTitanmagnetics®H.00.04.X1H.00.04.X12023-07-24
ESTOH0004X20StecoTitanmagnetics®H.00.04.X2H.00.04.X22023-07-24
ESTOH0004Z10StecoTitanmagnetics®H.00.04.Z1H.00.04.Z12023-07-24
ESTOH0004Z20StecoTitanmagnetics®H.00.04.Z2H.00.04.Z22023-07-24
ESTOH0004Z30StecoTitanmagnetics®H.00.04.Z3H.00.04.Z32023-07-24
ESTOH0004Z40StecoTitanmagnetics®H.00.04.Z4H.00.04.Z42023-07-24
ESTOI0102K1500StecoTitanmagnetics®I.01.02.K150I.01.02.K1502023-07-24
ESTOI0102K3000StecoTitanmagnetics®I.01.02.K300I.01.02.K3002023-07-24
ESTOI0102X3250StecoTitanmagnetics®I.01.02.X325I.01.02.X3252023-07-24

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