FDA.reportPublic FDA data

DEFINA

Primary DI
04961333249176
Brand
DEFINA
Company
HOYA CORPORATION
Model
EPK-3000
Device description
PENTAX Medical Video Processor EPK-3000
Published
2023-10-31
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
PEAEndoscope, accessories, image post-processing for color enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172156000PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical2018-04-05EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333249176Direct MarkingGS10
04961333249183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333249176049613332491764961333249176
04961333249183049613332491834961333249183

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691519705
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255801INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255825INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255818INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255832INSPIRAHOYA CORPORATIONPEA2025-06-20
04547410513790FUJIFILMFUJIFILM CORPORATIONPEA2025-05-31
04961333251605PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251049PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333251025PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333254910INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333254934INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333249183DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
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
04961333247974INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333247929INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333075157PENTAXHOYA CORPORATIONPEA2023-09-15
04961333247462PENTAX MedicalHOYA CORPORATIONPEA2023-09-15
04961333132607PENTAXHOYA CORPORATIONPEA2023-08-18
04961333070367PENTAXHOYA CORPORATIONPEA2023-07-31
04961333075164PENTAXHOYA CORPORATIONPEA2023-07-31
04961333077984PENTAXHOYA CORPORATIONPEA2023-07-31