FDA.reportPublic FDA data

"32"" 4K OLED Surgical Display"

Primary DI
07613327592146
Brand
"32"" 4K OLED Surgical Display"
Company
STRYKER CORPORATION
Model
0240031300
Catalog number
0240031300
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWBCAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWBCamera, Television, Surgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327592146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327592146076133275921467613327592146

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195174123508LGLG Electronics Inc.FWB2025-07-24
00195174123515LGLG Electronics Inc.FWB2025-07-24
00195174113875LGLG Electronics Inc.FWB2025-01-08
00195174112779LGLG Electronics Inc.FWB2024-12-13
00195174081310LGLG Electronics Inc.FWB2023-11-30
00195174073216LGLG Electronics Inc.FWB2023-10-23
00195174073155LGLG Electronics Inc.FWB2023-09-12
00195174073179LGLG Electronics Inc.FWB2023-09-12
00195174073186LGLG Electronics Inc.FWB2023-09-12
06933741405183HisenseQingdao Hisense Medical Equipment Co., Ltd.FWB2023-09-11
00195174067154ARTHREXLG Electronics Inc.FWB2023-06-19
00195174053850LGLG Electronics Inc.FWB2023-05-10
00195174061435LGLG Electronics Inc.FWB2023-03-08
00859151005286MTSMEDICAPTURE, INC.FWB2023-02-21
00195174047316LGLG Electronics Inc.FWB2022-09-26
00195174027059LGLG Electronics Inc.FWB2022-06-07
00195174033753LGLG Electronics Inc.FWB2022-06-07
00700621719533StrykerBarco, Inc.FWB2022-03-02
00700621719557StrykerBarco, Inc.FWB2022-03-02
00700621719564StrykerBarco, Inc.FWB2022-03-02
00700621719571StrykerBarco, Inc.FWB2022-03-02
00700621719588StrykerBarco, Inc.FWB2022-03-02
00195174025604LGLG Electronics Inc.FWB2021-09-07
00195174004524LGLG Electronics Inc.FWB2020-10-15
00195174006764LGLG Electronics Inc.FWB2020-10-15
09352527000775Visionflex VISIONFLEX PTY. LTD.FWB2020-08-17
00719192609198LGLG Electronics Inc.FWB2020-06-08
00719192609600LGLG Electronics Inc.FWB2020-06-08
00719192617605LGLG Electronics Inc.FWB2020-06-08
00719192624214LGLG Electronics Inc.FWB2020-06-08