FDA.report

Paradigm

Primary DI
00850042604106
Brand
Paradigm
Company
Proprio, Inc.
Model
1100004
Catalog number
1100004
Device description
Monitor and Stand for Paradigm System
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K222291000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222291000Paradigm SystemProprio, Inc.2023-04-21OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850042604106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042604106008500426041068500426041060850042604106

GMDN Terms

TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods

Method

Contacts

PhoneEmail
2068486303customerservice@propriovision.com

Regulatory Flags

DUNS number
010254854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
00850042604366Paradigm Foot Switch110000811000082026-01-13
00850042604236 Paradigm Navigated Drill Guide Case Tray120002212000222025-06-09
00850042604243Paradigm Navigated Drill Guide Case Lid120002312000232025-06-09
00850042604274Paradigm Navigated Drill Guide120002412000242025-06-09
00850042604281Paradigm Drill Bit, 2.1 mm120002512000252025-06-09
00850042604298Paradigm Drill Bit, 3.0 mm120002612000262025-06-09
00850042604304Paradigm Depth Cannula, 2mm120002712000272025-06-09
00850042604311Paradigm Drill Guide Trocar120002812000282025-06-09
00850042604328Paradigm Depth Cannula, 5mm120003012000302025-06-09
00850042604335Paradigm Navigated Drill Guide Set120002012000202025-06-09
00850042604342Paradigm Navigated Drill Guide Case Assembly120002112000212025-06-09
00850042604014Paradigm110000611000062025-03-21
00850042604021Paradigm120000912000092025-03-21
00850042604113Paradigm120001112000112025-03-21
00850042604120Paradigm120001212000122025-03-21
00850042604137Paradigm120002912000292025-03-21
00850042604144Paradigm120001012000102025-03-21
00850042604151Paradigm120000812000082025-03-21
00850042604168Paradigm120001312000132025-03-21
00850042604175Paradigm120001412000142025-03-21

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