PENTAX

Primary DI
04961333115303
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B184
Device description
O-Ring Set For OF-B183 OF-B184
Published
2023-07-31
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
FAMSigmoidoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAMSigmoidoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951577000ES-3800, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.1996-03-21FAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333115303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333115303049613331153034961333115303

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic procedure air/water valve, reusableA non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
true
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
00732094139051Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-18
00732094139075Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-18
00732094080940Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
00732094080957Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
00732094080964Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
04547410436501FUJIFILMFUJIFILM CORPORATIONFAM2021-04-27
00732094080384Welch Allyn, Inc.WELCH ALLYN, INC.FAM2021-04-26
00732094080391Welch Allyn, Inc.WELCH ALLYN, INC.FAM2021-04-14
00732094200300Welch Allyn, Inc.WELCH ALLYN, INC.FAM2020-01-16
00732094079678Welch Allyn, Inc.WELCH ALLYN, INC.FAM2018-03-01
00732094080933Welch Allyn, Inc.WELCH ALLYN, INC.FAM2018-03-01
04961333070831PENTAXHOYA CORPORATIONFAM2017-04-07
04961333071425PENTAXHOYA CORPORATIONFAM2017-04-07
04961333228164PENTAXHOYA CORPORATIONFAM2017-04-07
04961333232635VIDEO SIGMOIDOSCOPEPENTAX OF AMERICA, INC.FAM2017-04-06
04961333232642VIDEO SIGMOIDOSCOPEPENTAX OF AMERICA, INC.FAM2017-04-06
04547410330977FUJIFILMFUJIFILM CORPORATIONFAM2016-12-14
04547410333299FUJIFILMFUJIFILM CORPORATIONFAM2016-12-14
04048551084373n.a.Karl Storz GmbH & Co. KGFAM2016-09-23
00732094236958Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-20
00732094144024Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-20
00732094106046Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-19
00732094106060Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-17
00732094144000Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-17
00749756173520DeRoyalDEROYAL INDUSTRIES, INC.FAM2016-09-12
50749756173525DeRoyalDEROYAL INDUSTRIES, INC.FAM2016-09-12