FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826925900
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
OS-A83
Device description
Keyboard For EPK-i7000 OS-A83
Published
2026-08-25
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
K150618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150618000PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc.2015-11-24PEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580826925900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826925900045808269259004580826925900

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic device remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

Regulatory Flags#

DUNS number
691559848
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
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
04580826920035PENTAX MedicalEG29-i20c2026-08-25
04580826920066PENTAX MedicalEG27-i20c2026-08-25
04580826920141PENTAX MedicalEC38-i20cL2026-08-25
04580826920271PENTAX MedicalEC34-i20cL2026-08-25
04580826920295PENTAX MedicalEC38-i20cWL2026-08-25
04580826920325PENTAX MedicalEG29-i10c2026-08-25
04580826920394PENTAX MedicalEC38-i10cL2026-08-25
04580826920462PENTAX MedicalEC34-i10cL2026-08-25
04580826920653PENTAX MedicalEE17-J102026-08-25
04580826920660PENTAX MedicalEG17-J102026-08-25
04580826920684PENTAX MedicalEB19-J10U2026-08-25
04580826920721PENTAX MedicalEG38-J10UT2026-08-25
04580826920769PENTAX MedicalEG36-J10UR2026-08-25
04580826920806PENTAX MedicalEG34-J10U2026-08-25
04580826920899PENTAX MedicalEB19-J102026-08-25
04580826920929PENTAX MedicalEB15-J102026-08-25
04580826920950PENTAX MedicalEB11-J102026-08-25
04580826921001PENTAX MedicalVNL11-J102026-08-25
04580826921056PENTAX MedicalVNL11-J102026-08-25
04580826921063PENTAX MedicalVNL8-J102026-08-25

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
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
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25