FDA.reportPublic FDA data

Van Sickle

Primary DI
00810207783305
Brand
Van Sickle
Company
VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED
Model
28-106
Catalog number
NA
Device description
"Cottle Chisel 7-1/4"" (184 mm) curved, 6mm diameter, graduations in centimeters"
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KANChisel, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KANChisel, NasalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810207783305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810207783305008102077833058102077833050810207783305

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18176567100mark@vssii.com

Regulatory Flags#

DUNS number
183897771
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810207780014Van Sickle04-107NA2025-11-24
00810207780021Van Sickle04-109NA2025-11-24
00810207780038Van Sickle04-1272025-11-24
00810207780045Van Sickle04-128NA2025-11-24
00810207780052Van Sickle04-1472025-11-24
00810207780069Van Sickle05-100NA2025-11-24
00810207780076Van Sickle05-101NA2025-11-24
00810207780083Van Sickle05-110NA2025-11-24
00810207780090Van Sickle05-111NA2025-11-24
00810207780106Van Sickle05-120NA2025-11-24
00810207780120Van Sickle05-124NA2025-11-24
00810207780137Van Sickle05-125NA2025-11-24
00810207780144Van Sickle05-130NA2025-11-24
00810207780151Van Sickle05-131NA2025-11-24
00810207780168Van Sickle05-140NA2025-11-24
00810207780175Van Sickle05-141NA2025-11-24
00810207780182Van Sickle05-200NA2025-11-24
00810207780199Van Sickle05-201A2025-11-24
00810207780205Van Sickle05-210NA2025-11-24
00810207780229Van Sickle05-215NA2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810207783299Van 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 FreerASPEN SURGICAL PRODUCTS, 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
G586E7841530Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18