SICAT Implant

Primary DI
D776IMPLANTV15
Brand
SICAT Implant
Company
SiCAT GmbH & Co. KG
Model
V1.5
Published
2019-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D776IMPLANTV15PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
333707003
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D776AIRV20400SICAT Air2.0.402022-01-12
D776ENDOV20400SICAT ENDOV2.0.402022-01-12
D776FUNCTIONV20400SICAT FUNCTIONV2.0.402022-01-12
D776IMPLANTV20400SICAT IMPLANTV2.0.402022-01-12
D77666224630SICAT Endo662246366224632018-04-09
D776AIRV200SICAT Air2.02019-08-19
D776GIV1920GALILEOS Implant1.9.261432052019-08-07
D776ENDOV200SICAT ENDOV2.02019-12-12
D776FUNCTIONV200SICAT FUNCTIONV2.02019-12-12
D776IMPLANTV150SICAT IMPLANTV1.52019-12-12
D776IMPLANTV200SICAT IMPLANTV2.02019-12-12
D776SUITEV200SICAT SUITEV2.02019-12-12
D776ENDOV20SICAT ENDOV2.02019-09-08
D776FUNCTIONV20SICAT FUNCTIONV2.02019-09-08
D776SUITEV20SICAT SUITEV2.02019-09-08
D776SBPV100SICAT Bite Plate10300100103001002024-02-26
D776103000SICAT Bite Plate (Kit)10300103002023-06-13
D776OSLEEPV110SICAT OPTISLEEPV1.1104012023-08-03
D776OSLEEPV11SICAT OPTISLEEPV1.1104012022-10-21
D776104010SICAT OPTISLEEP10401104012016-08-31

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