FDA.reportPublic FDA data

SONY

Primary DI
04961333244362
Brand
SONY
Company
PENTAX OF AMERICA, INC.
Model
UP-21MD
Device description
SONY A6 COLOR VIDEO PRINTER 400DPI
Published
2018-03-15
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

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333244362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333244362049613332443624961333244362

GMDN Terms#

Term, Definition table
TermDefinition
Video printerA device designed for making printed (hard) copies of medical video images. These can be taken by digital cameras or image processing results of different imaging devices or systems [e.g., ultrasound (US), magnetic resonance imaging (MRI), computed tomography (CT) or radiographic images].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255696Digital Capture v3.7.09380 2025-09-12
04961333255979 MICROPHONE ASSAY KIT6651 2025-07-21
04961333255986Disposables Kit6650 2025-07-21
04961333255016LARYNGOSTROBOSCOPE95002025-04-25
04961333255702LARYNGOSTROBOSCOPE9500LX2025-04-25
04961333255719LARYNGOSTROBOSCOPE9500MC2025-04-25
04961333255726LARYNGOSTROBOSCOPE9500FS2025-04-25
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333254309MULTI-SPEECH3706-12023-08-25
04961333248117Pentax of America93802022-11-04
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333248001ENDOPRO REVIEW WORKSTATIONKBM68344NA2020-03-26
04961333248018ENDOPRO NETWORK CAPTURE WORKSTATIONKBM683452020-03-26
04961333248025ENDOPRO STANDALONEC CAPTURE WORKSTATIONKBM683462020-03-26
04961333244355BRANDMAXU-5LH2018-03-15
04961333244188N/AOS-H52018-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00818089022437RadianceNds Surgical Imaging LLCKQM2026-02-10
08800025400692EZ SHOT SEGOOD DOCTORS CO., LTD.KQM2026-01-15
05415334050020BarcoBarco NVKQM2025-12-22
05415334050013BarcoBarco NVKQM2025-12-01
00819761023032Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-25
00819761023049Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-24
00860012447107EclipseInnovations Lightx IncKQM2025-11-12
00724995245061HexaVueBLACK DIAMOND VIDEO, INC.KQM2025-10-17
00810000890712FSNFORESEESON CUSTOM DISPLAYS, INC.KQM2025-09-15
04548736170698SONYSONY CORPORATIONKQM2025-09-12
04548736170711SONYSONY CORPORATIONKQM2025-09-12
07613327661194In-Light CameraSTRYKER COMMUNICATIONS INC.KQM2025-08-27
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
04995047069867CuratOREIZO CORPORATIONKQM2025-07-18
04995047070320CuratOREIZO CORPORATIONKQM2025-07-18
00840183530402BR Surgical, LLCBR Surgical, LLCKQM2025-07-16
20618125114669SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170728SONYSONY CORPORATIONKQM2025-07-08
04548736170742SONYSONY CORPORATIONKQM2025-07-08
06972039971085MOPTIMShenzhen CERTAINN Technology Co., Ltd.KQM2025-06-30
00860014100642AmimonRocoto Inc.KQM2025-06-24
00860014100659AmimonRocoto Inc.KQM2025-06-24
05415334051133SterisBarco NVKQM2025-06-05
04548736167117SONYSONY CORPORATIONKQM2025-05-30
04548736167124SONYSONY CORPORATIONKQM2025-05-30