FDA.reportPublic FDA data

OsstellConnect

Primary DI
09010522001073
Brand
OsstellConnect
Company
Osstell AB
Model
Osstell OsstellConnect
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09010522001073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09010522001073090105220010739010522001073

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
633171269
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010522002513SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002537SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002506SmartPeg Type 127SmartPeg Type 1271008102026-02-09
09010522002520SmartPeg Type 137SmartPeg Type 1371008112026-02-09
09010522002674MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002650Osstell Beacon InstrumentOsstell Beacon Instrument1030002025-09-26
09010522002667MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002025-09-26
09010522002636Osstell Classic InstrumentOsstell Classic Instrument080861482025-03-23
09010522002575Osstell SmartPeg Type 113Osstell SmartPeg Type 113080861452025-03-27
09010522002599Osstell SmartPeg Type 114Osstell SmartPeg Type 114080861462025-03-27
09010522002612Osstell SmartPeg Type 115Osstell SmartPeg Type 115080861472025-03-27
09010522002551Osstell SmartPeg Type 112Osstell SmartPeg Type 112080861442025-03-27
09010522002568Osstell SmartPeg Type 113Osstell SmartPeg Type 113080861452025-03-27
09010522002582Osstell SmartPeg Type 114Osstell SmartPeg Type 114080861462025-03-27
09010522002605Osstell SmartPeg Type 115Osstell SmartPeg Type 115080861472025-03-27
09010522000885Osstell Beacon InstrumentOsstell Osstell Beacon Instrument1030002022-09-02
09010522000892Osstell IDx InstrumentOsstell Osstell IDx Instrument1010002022-11-01
09010522001097MEGA ISQ II InstrumentOsstell MEGA ISQ II Instrument1031002022-09-02
09010522001141DIO IDx InstrumentOsstell DIO IDx Instrument1005012022-11-01
09010522001189Osstell SmartPeg Type 03Osstell SmartPeg Type 031003572022-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28