FDA.reportPublic FDA data

STEPHANIX

Primary DI
03664049001038
Brand
STEPHANIX
Company
STEPHANIX
Model
D2RS_9090_B1_N
Device description
D2RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography. Not for mammography.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213479000D²RS and D²RS 9090Stephanix2021-12-23OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664049001038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664049001038036640490010383664049001038

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure760 millibar1050 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1050 millibar
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381826536
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664049000017STEPHANIXD2RS2016-10-22
03664049000024STEPHANIXD2RS_AT2016-10-22
03664049902366STEPHANIXMOVIX DReamy_10202023-08-01
03664049902472STEPHANIXMOVIX DReamy_10322023-08-01
03664049902489STEPHANIXMOVIX DReamy_10402023-08-01
03664049902496STEPHANIXMOVIX DReamy_10502023-08-01
03664049000031STEPHANIXD2RS_B1_N2023-06-05
03664049000048STEPHANIXD2RS_AT_PA2023-06-05
03664049000055STEPHANIXD2RS_B1_NV22023-06-05
03664049000062STEPHANIXD2RS_AT_PA_NV22023-06-05
03664049001045STEPHANIXD2RS_9090_AT_PA2023-06-05
03664049001052STEPHANIXD2RS_9090_B1_NV22023-06-05
03664049001069STEPHANIXD2RS_9090_AT_PA_NV22023-06-05

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