FDA.reportPublic FDA data

INKA

Primary DI
09348811103574
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33934.03
Catalog number
33934.03
Device description
Biopsy & Grasping Forceps double action cupped jaw 3x6mm cup 70° up-horizontal shaft length 130mm
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811103574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811103574093488111035749348811103574

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

Regulatory Flags#

DUNS number
742109993
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348811101655INKA30522.192026-04-24
09348811102522INKA36239.212026-04-24
09348811103796INKA33945.022026-04-24
09348811104236INKA31559.092026-04-24
09348811104595INKA31572.09 BL2026-04-24
09348811104908INKA33261.252026-04-24
09348811104915INKA33261.302026-04-24
09348811104953INKA33264.252026-04-24
09348811105653INKA33244.302026-04-24
09348811105707INKA33245.302026-04-24
09348811109408INKA31405.352026-04-24
09348811109415INKA31405.402026-04-24
09348811111975INKA31252.202026-04-24
09348811114891INKA31683.09 BL2026-04-24
09348811115829INKA33866.212026-04-24
09348811116673INKA33125.022026-04-24
09348811172099INKA31576.062026-04-24
09348811099037INKA31367.062026-04-10
09348811150233INKA31286.26 RD2026-04-10
09348811003119INKA10415.182026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316049OSSEOUS Tilley's Nasal Dressings Forceps EON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039319699OSSEOUS Micro Alligator Ear ForcepesEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
G586NS80152710Novo SurgicalNOVO SURGICAL, INC.KAE2024-02-22
07898506842704QuinelatoSchobell Industrial LtdaKAE2023-01-09
10381780406815Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780407072Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780402855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402954Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402961Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402985Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402992Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780403012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780403036Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03