FDA.reportPublic FDA data

Van Sickle

Primary DI
00810207783657
Brand
Van Sickle
Company
VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED
Model
30-826
Catalog number
NA
Device description
"Fomon Rasp 8-1/2"" (216 mm) double ended, #5 and #6, back, Tungsten Carbide Tips"
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
GACRasp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810207783657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810207783657008102077836578102077836570810207783657

GMDN Terms#

Term, Definition table
TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
B35675400020American MedicalsAmerican MedicalsGAC2026-05-20
05055445940881SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940898SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940904SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940911SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940928SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973001SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973018SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973032SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
00190776421014MillenniumAvalign Technologies, Inc.GAC2026-04-30
B356ED469970American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470040American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470050American MedicalsAmerican MedicalsGAC2026-04-07
B356FF114000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115020American MedicalsAmerican MedicalsGAC2025-05-27
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29