FDA.reportPublic FDA data

Orthonol

Primary DI
00885797019837
Brand
Orthonol
Company
Rmo, Inc.
Model
A07075
Device description
ORTHONOL(R) PREFORM NATURAL ARCH MX .017 X .025 34MM
Published
2024-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797019837PrimaryGS10
00000008857972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797019837008857970198378857970198370885797019837
00000008857972000000088579720000088579720000008857972

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
007058183
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885797644862TruLockJ040202024-08-23
00885797644879TruLockJ040212024-08-23
00885797664891TruLockJ040222024-08-23
00885797664907TruLockJ040232024-08-23
00885797664914TruLockJ040242024-08-23
00885797018403OrthonolA07408-12024-09-04
00885797526977FLI TwinM051502024-09-04
00885797019134ThermaloyA077102024-09-03
00885797099815TruFormK003292024-09-03
00885797099822TruFormK003302024-09-03
00885797099839TruFormK003312024-09-03
00885797099846TruFormK003322024-09-03
00885797099853TruFormK003332024-09-03
00885797099860TruFormK003342024-09-03
00885797099884RMOK004552024-09-03
00885797099891TruFormK005102024-09-03
00885797099907TruFormK005122024-09-03
00885797099914TruFormK005142024-09-03
00885797099921TruFormK005162024-09-03
00885797099938TruFormK005182024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521852273BIS AdvanceCovidien LPORT2026-10-26
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.ORT2026-09-04
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyORT2026-04-15
00000008857972RMORmo, Inc.ORT2024-08-12
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCORT2024-05-13
10884521808270BISCovidien LPORT2024-04-28
10884521808300BISCovidien LPORT2024-04-28
10884521808317BISCovidien LPORT2024-04-28
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDORT2023-08-18
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDORT2023-08-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyORT2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyORT2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyORT2023-04-19
00195278524089NAGE Healthcare Finland OyORT2023-04-19
00195278466662E-EEGXGE Healthcare Finland OyORT2022-07-01
00195278466679N-EEGXGE Healthcare Finland OyORT2022-07-01
00840682146111CARESCAPE B650GE Healthcare Finland OyORT2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyORT2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyORT2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.ORT2022-04-12