FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826928598
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
OF-B182
Device description
O-Ring Set For OF-B113 OF-B182
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
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580826928598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826928598045808269285984580826928598

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, reusableA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a reusable device.

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
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926112PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926150PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926228PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926273PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926280PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928420PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928437PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25