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
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24