FDA.reportPublic FDA data

INKA

Primary DI
09348811010155
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
12278.15
Catalog number
12278.15
Device description
DeBAKEY atraumatic Tissue Forceps 2.0mm tip 15cm
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811010155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811010155093488110101559348811010155

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
G586D75480250NovosurgicalNOVO SURGICAL, INC.GEN2024-12-30
KTS1017012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1018012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1222112K.T.SurgicoK.T.SURGICOGEN2024-02-20
GYNX32071GynexGYNEX CORPORATIONGEN2023-12-26
07898506812424QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812479QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812516QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812639QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812646QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812691QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812769QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812806QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812813QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813803QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813810QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506850198QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506852772QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506853274QuinelatoSchobell Industrial LtdaGEN2023-01-10