FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333247462
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OS-A115
Device description
PENTAX Medical Keyboard EN OS-A115
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333247462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333247462049613332474624961333247462

GMDN Terms#

Term, Definition table
TermDefinition
Computer/medical device keyboardA desktop, electronic component of a computer/medical device intended to operate and/or control the use of the parent device. It has a panel of keys, including alpha-numeric characters, and may have touchscreen capability and/or specialized keys to control specialized functionality of the parent device. It is not dedicated to those with a disability.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04961333248209PENTAXEC38-i10L2020-12-14
04961333248315PENTAXEG29-i102020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333246779PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246830PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246847PENTAXHOYA CORPORATIONFDS2025-04-04
04961333246939PENTAXHOYA CORPORATIONFDS2025-04-04
04961333254316PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254323PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254330PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254347PENTAXHOYA CORPORATIONFDF2024-07-26
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333249183DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONFDF2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONFDS2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252145PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252145PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDS2023-09-20