FDA.reportPublic FDA data

PENTAX

Primary DI
04961333085453
Brand
PENTAX
Company
HOYA CORPORATION
Model
OL-Z3
Device description
Capacitor Grounding Cable OL-Z3
Published
2023-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K122470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122470000PENTAX EPK-I5010 VIDEO PROCESSORPentax Medical2013-04-10PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333085453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333085453049613330854534961333085453

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925153OPTIVISTAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925245DEFINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925450IMAGINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925696PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925849PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925856PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925894PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925900PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826927447PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25