FDA.reportPublic FDA data

MiniFESS

Primary DI
00857326005451
Brand
MiniFESS
Company
STRYKER CORPORATION
Model
CS-105
Device description
Sickle Knife
Published
2020-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KTGKnife, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857326005451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857326005451008573260054518573260054510857326005451

GMDN Terms#

Term, Definition table
TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30
07613327507997Stroke Fast PackSFP913100SFP9131002020-06-30
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770676521Bausch + LombBausch & Lomb IncorporatedKTG2026-06-22
00810220800300Adler Instrument CompanyAdler, Inc.KTG2026-06-02
00840343727550Gen2SURGIX MEDICAL LLCKTG2026-04-22
00840343727314GEN2SURGIX MEDICAL LLCKTG2026-04-16
00840343727321GEN2SURGIX MEDICAL LLCKTG2026-04-16
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613056407MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613102609MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108700MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108762MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613118037MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613119621MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00757770422234Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00757770423699Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00190776406615MillenniumAvalign Technologies, Inc.KTG2025-07-23
00190776405694MillenniumAvalign Technologies, Inc.KTG2025-07-18
00190776397647MillenniumAvalign Technologies, Inc.KTG2025-05-16
00194613047504MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056353MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056360MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056391MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21