FDA.reportPublic FDA data

PENTAX

Primary DI
04961333224449
Brand
PENTAX
Company
HOYA CORPORATION
Model
KW1815S
Device description
FORCEPS WITH WINDOW
Published
2017-04-07
Public version status
Update
Distribution status
Not 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
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333070978Direct MarkingGS10
04961333224449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333070978049613330709784961333070978
04961333224449049613332244494961333224449

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Sound Waves

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
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
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
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
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926167PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926198PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926204PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926235PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926242PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926259PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926266PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926549PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826927027PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25