FDA.reportPublic FDA data

INKA

Primary DI
09348811009135
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
12204.12
Catalog number
12204.12
Device description
SEMKEN Dissecting Forceps delicate 1x2 teeth 12.5cm
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
09348811009135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811009135093488110091359348811009135

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
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811115461INKA36187.132026-06-02
09348811148858INKA30149.052026-06-02
09348811148889INKA30149.082026-06-02
09348811148957INKA30124.502026-06-02
09348811100603INKA30260.002026-05-29
09348811100825INKA31210.012026-05-29
09348811100832INKA31210.022026-05-29
09348811105417INKA30445.252026-05-29
09348811109439INKA31405.502026-05-29
09348811114068INKA30727.172026-05-29
09348811114075INKA30728.172026-05-29
09348811148919INKA30124.302026-05-29
09348811148933INKA30124.402026-05-29
09348811150301INKA31243.16 RD2026-05-29
09348811150318INKA31252.04 RD2026-05-29
09348811150325INKA31252.06 RD2026-05-29
09348811150349INKA31252.10 RD2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-09
00810189451506Surgical DesignSurgical Design, Inc.GEN2026-06-06
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450264Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450271Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450288Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450295Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450301Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450318Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450325Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450332Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450349Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450356Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450363Surgical DesignSurgical Design, Inc.GEN2026-05-29
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
09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19