FDA.reportPublic FDA data

INKA

Primary DI
09348811019400
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
15127.16
Catalog number
15127.16
Device description
SENN-MILLER Catspaw Retractor blunt 16cm
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
FGNRetractor, Non-Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811019400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811019400093488110194009348811019400

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
09348811019394INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
07898506814732QuinelatoSchobell Industrial LtdaFGN2023-01-09
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780270256Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268567Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23