FDA.reportPublic FDA data

PENTAX

Primary DI
04961333075348
Brand
PENTAX
Company
HOYA CORPORATION
Model
OS-H4
Device description
WATER BOTTLE ASSEMBLY OS-H4
Published
2020-09-23
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
04961333075348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333075348049613330753484961333075348

GMDN Terms#

Term, Definition table
TermDefinition
Sterile solution storage bottle, reusableAn empty glass or plastic container, typically with a relatively narrow neck and capable of being sterilized, intended for the safe storage and easy handling of sterile solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Sound Waves""]"
Moist Heat or Steam Sterilization;Sound Waves

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Sterilization required before use
true

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
04961333249176DEFINAHOYA 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