Nobilium

Primary DI
M482D1EN0
Brand
Nobilium
Company
CMP INDUSTRIES LLC
Model
D1EN
Device description
DENTURE ID MICROCHIPDENTURE ID MICROCHIP
Published
2018-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYQRfid Chip For Dental Appliance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYQRfid Chip For Dental ApplianceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170423000DentureID MicrochipCmp Industries, LLC2017-10-25PYQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M482D1EN0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency identification patient positioning/tracking systemAn assembly of hardware/software devices intended to employ radio-frequency identification (RFID) techniques to aid in the correct identification and positioning of the patient during a diagnostic imaging, treatment planning or radiation therapy procedure. It typically consists of RFID tags worn by the patient or embedded/attached to treatment accessories, a RFID reader, optical markers and optical camera, monitor, and hand-held control unit; it may also use an infrared tracking camera and/or a video camera.

Regulatory Flags#

DUNS number
002064319
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M48233010NOBILIUM33012016-11-17
M48233050NOBILIUM33052016-11-17
M48233060NOBILIUM33062016-11-17
M48233070NOBILIUM33072016-11-17
M48233071K0NOBILIUM3307-1K2016-11-17
M48233110NOBILIUM33112016-11-17
M4823311GB0NOBILIUM3311GB2016-11-17
M48233120NOBILIUM33122016-11-17
M48233130NOBILIUM33132016-11-17
M48233140NOBILIUM33142016-11-17
M4823314GB0NOBILIUM3314GB2016-11-17
M48233170NOBILIUM33172016-11-17
M48233190NOBILIUM33192016-11-17
M48234100NOBILIUM34102016-11-17
M48237460NOBILIUM37462016-11-17
M48237470NOBILIUM37472016-11-17
M4823747GB0NOBILIUM3747GB2016-11-17
M48237480NOBILIUM37482016-11-17
M4823748GB0NOBILIUM3748GB2016-11-17
M48237490NOBILIUM37492016-11-17