FDA.reportPublic FDA data

PENTAX

Primary DI
04961333224258
Brand
PENTAX
Company
HOYA CORPORATION
Model
FNL-10RP3
Device description
NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES
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

Product Codes#

Code, Name table
CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333070916Direct MarkingGS10
04961333224258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333070916049613330709164961333070916
04961333224258049613332242584961333224258

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic nasopharyngolaryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide
High-level Disinfectant

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
false
Serial number
true
Manufacturing date on label
true
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
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921063PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926358PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926433PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927034PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927041PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826928710PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
04961333256181PENTAXHOYA CORPORATIONEOB2026-08-25
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16