FDA.report

PENTAX

Primary DI
04961333086375
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B177
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333086375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04961333086375049613330863754961333086375

GMDN Terms

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
Ethylene Oxide;Sound Waves;High-level Disinfectant;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
691519705
Device count
1
DM exempt
false
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 DIBrandModelCatalogPublished
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333255818INSPIRAEPK-i8020c2025-06-20
04961333255832INSPIRAEPK-i8020c2025-06-20
04961333356478PENTAX MedicalEC38-i20cWL2025-04-28
84961333253919PENTAXOE-A522025-04-08
04961333129430PENTAXEC-3890Li2025-04-04
04961333172085PENTAXEC38-i10L2025-04-04
04961333129492PENTAXEG-2990i2025-04-04
04961333211692PENTAXEG29-i102025-04-04
04961333251070PENTAXOF-B1942025-04-04
84961333253902PENTAXOE-A512025-04-04
84961333253933PENTAXOE-A602025-04-04
84961333253957PENTAXOF-A672025-04-04
04961333254620PENTAX MedicalOE-B172024-12-13
04961333356393PENTAX MedicalEG27-i20c2024-12-13
04961333356416PENTAX MedicalEC34-i20cL2024-12-13
04961333356331PENTAX MedicalED34-i10T2s2024-09-03
04961333254781PENTAXEC-2990Li2024-07-26
04961333254460PENTAXEC34-i10L2024-07-26

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