FDA.reportPublic FDA data

INKA

Primary DI
09348811115461
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
36187.13
Device description
FOMON-TC Dissecting Scissors serrated semi-sharp outer edges curved 13.5cm
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811115461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811115461093488111154619348811115461

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
742109993
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
09348811083098INKA20706.182026-07-31
09348811100542INKA30258.002026-07-31
09348811102645INKA31351.172026-07-31
09348811102669INKA31352.172026-07-31
09348811103291INKA36429.052026-07-31
09348811109194INKA31278.162026-07-31
09348811111951INKA31252.122026-07-31
09348811111982INKA31255.042026-07-31
09348811112026INKA31255.152026-07-31
09348811114846INKA31657.132026-07-31
09348811150257INKA31287.20 RD2026-07-31
09348811155320INKA31255.032026-07-31
09348811155337INKA31255.122026-07-31
09348811109798INKA30370.192026-07-30
09348811149756INKA31254.062026-07-30
09348811146069INKA33343.202026-07-03
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811148858INKA30149.052026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433864MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436278MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436292MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776433635MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434403MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434496MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434502MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434519MillenniumAvalign Technologies, Inc.LRW2026-10-07
G141510457190Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-10-07
00190776433987MillenniumAvalign Technologies, Inc.LRW2026-10-06
00190776433994MillenniumAvalign Technologies, Inc.LRW2026-10-06
10841767100537Trinity Sterile, Inc.Trinity Sterile, Inc.LRW2026-10-06
00190776435882MillenniumAvalign Technologies, Inc.LRW2026-09-30
04059453158284Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30
04059453158307Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30
G141509455170Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G141510586170Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G1415241110Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
G141560733410Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-09-30
00810130207565MSIModern Surgical Instruments LLCLRW2026-09-28
04059453052568Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-28
00724995268848Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268855Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268862Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268879Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268886Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268893Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268909Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00190776432355MillenniumAvalign Technologies, Inc.LRW2026-09-24
00810238290001PRINCETONPrinceton Medical Group, Inc.LRW2026-09-22