FDA.report

N/A

Primary DI
04961333242559
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
92192/12
Device description
SVGA BREAKOUT, HD15 MALE/5BNC MALE 12
Published
2018-03-08
Public version status
Update
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

Product Codes

CodeName
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications

CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333242559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04961333242559049613332425594961333242559

GMDN Terms

TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Device Sizes

TypeValueUnit
Length12Feet

Sterilization Methods

Method

Regulatory Flags

DUNS number
083211284
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 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 DIBrandCompanyProduct codePublished
04961333255818INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255832INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333251605PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251025PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333254934INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333249176DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333251827PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251858INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333251896INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333247929INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333075157PENTAXHOYA CORPORATIONPEA2023-09-15
04961333247462PENTAX MedicalHOYA CORPORATIONPEA2023-09-15
04961333132607PENTAXHOYA CORPORATIONPEA2023-08-18
04961333085453PENTAXHOYA CORPORATIONPEA2023-07-31
04961333172528PENTAXHOYA CORPORATIONPEA2023-07-31
04961333175000PENTAXHOYA CORPORATIONPEA2023-07-31
04961333175017PENTAXHOYA CORPORATIONPEA2023-07-31
04961333216864PENTAXHOYA CORPORATIONPEA2023-07-31
04961333075348PENTAXHOYA CORPORATIONPEA2020-09-23
04547410384543FUJIFILMFUJIFILM CORPORATIONPEA2020-07-20
04961333233670IMAGINAHOYA CORPORATIONPEA2020-07-17
04961333244874DEFINAHOYA CORPORATIONPEA2020-07-17
04961333233618OPTIVISTAHOYA CORPORATIONPEA2018-08-10
04961333225262DEFINAPENTAX OF AMERICA, INC.PEA2018-04-16