FDA.report

West lacrimal sac chisel

Primary DI
G2231146000
Brand
West lacrimal sac chisel
Company
Medetz Surgical Instruments LLC
Model
11-4600
Device description
West lacrimal sac chisel, 6mm wide blade, square handle 71/2"
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KANChisel, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
KANChisel, NasalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G2231146000PrimaryHIBCC0

GMDN Terms

TermDefinition
Nasal chiselA single-bladed, surgical instrument, bevelled on one side that is used to cut and shape the nasal bones during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8004205135emichaels@medetzsurgical.com

Regulatory Flags

DUNS number
876570990
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
G2231135500Medetz Surgical Instruments11-35502025-12-16
G2231135900Medetz Surgical Instruments11-35902025-12-16
G2231394680Sinskey lens manipulating hook13-94682025-12-16
G223M1129350Femtosecond Spatulam11-29352025-12-16
G223113858L0Medetz Surgical Instruments11-3858L2025-09-05
G2231140730Medetz Surgical Instruments11-40732025-09-05
G22312449840Medetz Surgical Instruments12-449842025-09-05
G22312479090Medetz Surgical Instruments12-479092025-09-05
G2231310110Medetz Surgical Instruments13-10112025-09-05
G22312406080Medetz Surgical Instruments12-406082025-08-21
G2231109830Medetz Surgical Instruments11-09832025-08-11
G2231115290Medetz Surgical Instruments11-15292025-08-11
G2231196790Medetz Surgical Instruments11-96792025-08-11
G22312244990Medetz Surgical Instruments12-244992025-08-11
G2231244970T0Medetz Surgical Instruments12-44971t2025-08-11
G2231458300Medetz Surgical Instruments14-58302025-08-11
G223997034050Medetz Surgical Instruments99-7034052025-08-11
G2231523360Medetz Surgical Instruments15-23362025-06-30
G2231317450Medetz Surgical Instruments13-17452025-06-26
G223M1113100Medetz Surgical Instrumentsm11-13102025-06-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810207783299Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
00810207783305Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
04250676731142ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731159ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731166ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731173ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731180ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731197ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731517ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676740540Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04250676740557Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04049047120520GimmiGimmi GmbHKAN2025-05-21
04049047121251GimmiGimmi GmbHKAN2025-05-21
04049047387459GimmiGimmi GmbHKAN2025-05-21
00887482146286Symmetry Surgical®SYMMETRY SURGICAL INC.KAN2024-08-15
00888515236646BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236653BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236660BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236677BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236684BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236691BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
G586E3871130Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871140Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871150Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871160Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871170Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871190Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841400Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841450Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841480Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18