FDA.reportPublic FDA data

PENTAX

Primary DI
04961333071425
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B53
Device description
Suction Control Valve
Published
2017-04-07
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333071425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333071425049613330714254961333071425

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Sound Waves"", ""High-level Disinfectant""]"
Ethylene Oxide;Sound Waves;High-level Disinfectant

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Manufacturing date on label
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
04961333115303PENTAXHOYA CORPORATIONFAM2023-07-31
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
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