PENTAX

Primary DI
04961333224722
Brand
PENTAX
Company
HOYA CORPORATION
Model
KH2411S
Device description
FORCEPS WITH WINDOW/SPIKE
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

Product Codes#

Code, Name table
CodeName
GCLESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCLEsophagoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951198000FE-34TH, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.1995-05-30GCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333083473Direct MarkingGS10
04961333224722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333083473049613330834734961333083473
04961333224722049613332247224961333224722

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""]"
Moist Heat or Steam Sterilization;Sound Waves

Regulatory Flags#

DUNS number
691519705
Device count
1
Serial number
true
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
16971381251613Single-use Biopsy ForcepsSCIVITA MEDICAL TECHNOLOGY CO., LTD.GCL2023-05-24
00812608021581PMIPROGRESSIVE MEDICAL, INC.GCL2017-10-04
10812608021588PMIPROGRESSIVE MEDICAL, INC.GCL2017-10-04
04961333224746PENTAXHOYA CORPORATIONGCL2017-04-07
04961333224784PENTAXHOYA CORPORATIONGCL2017-04-07
04961333224807PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227471PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227495PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227518PENTAXHOYA CORPORATIONGCL2017-04-07
04961333227532PENTAXHOYA CORPORATIONGCL2017-04-07
04961333232741FIBER ESOPHAGOSCOPEPENTAX OF AMERICA, INC.GCL2017-04-06
00812608021314PMIPROGRESSIVE MEDICAL, INC.GCL2016-09-23
00812608021376PMIPROGRESSIVE MEDICAL, INC.GCL2016-09-23