FDA.reportPublic FDA data

N/A

Primary DI
04961333244171
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
OF-Z5K
Device description
STANDARD BITE BLOCKS, 3 PIECES
Published
2018-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850020000PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23Pentax Precision Instrument Corp.1985-07-09FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333244171PrimaryGS10
14961333244178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333244171049613332441714961333244171
1496133324417814961333244178

GMDN Terms#

Term, Definition table
TermDefinition
Seizure bite blockA non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Sound Waves""]"
Ethylene Oxide;Sound Waves

Regulatory Flags#

DUNS number
083211284
Device count
3
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDS2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDS2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDS2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDS2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDS2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDS2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDS2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDS2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDS2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDS2026-10-16
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921230PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921353PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921865PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921940PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921957PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25