FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826927089
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
OF-B84
Device description
O-Ring for Adjustable Luer Lock Seal (OF-B82) 10pcs OF-B84
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
FBNCholedochoscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953286000FCP-9P, FIBER CHOLEDOCHOSCOPEPentax Precision Instrument Corp.1995-11-03FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580826927089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826927089045808269270894580826927089

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument seal/seal maintenance setA seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.

Sterilization Methods#

Method table
Method
Ethylene Oxide
High-level Disinfectant
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691559848
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
04580826926938PENTAX MedicalPENTAX MEDICAL CORPORATIONFBN2026-08-25
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06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFBN2026-07-28
04055207066805NARichard Wolf GmbHFBN2026-06-02
04055207007709NARichard Wolf GmbHFBN2026-05-29
04055207007723RIWORichard Wolf GmbHFBN2026-05-29
04055207007747NARichard Wolf GmbHFBN2026-05-29
04055207007792NARichard Wolf GmbHFBN2026-05-29
04055207007815NARichard Wolf GmbHFBN2026-05-29
04055207007839NARichard Wolf GmbHFBN2026-05-29
04055207008409NARichard Wolf GmbHFBN2026-05-29
04055207038505RIWORichard Wolf GmbHFBN2026-05-29
04055207038529RIWORichard Wolf GmbHFBN2026-05-29
04055207038536RIWORichard Wolf GmbHFBN2026-05-29
00850061601001Tangent Digital catheterTangent Endoscopy LLCFBN2026-04-08
06932503571210eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
26932503571214eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
06973786291563Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FBN2025-03-20
16973786290518Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-20
06973786291570Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FBN2025-03-19
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FBN2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FBN2024-09-14
04055207038512RIWORichard Wolf GmbHFBN2024-08-19
04055207008607NARichard Wolf GmbHFBN2024-08-19
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCFBN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546290Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546306Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11