FDA.reportPublic FDA data

Van Sickle

Primary DI
00810207783930
Brand
Van Sickle
Company
VAN SICKLE SURGICAL INSTRUMENTS, INCORPORATED
Model
36-300
Catalog number
NA
Device description
"Schamberg Comedone Extractor 3-3/4"" (95 mm), double ended, square loops"
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810207783930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810207783930008102077839308102077839300810207783930

GMDN Terms#

Term, Definition table
TermDefinition
Comedo expressorA manual instrument designed for pressing or squeezing out a comedo (black head) from the mouth of sebaceous follicles. It typically consists of a hand-held device with one or both ends appropriately configured (e.g., crimped, spoon-like, forming loops) for the extraction of plugging comedos. The instrument is used in the treatment of acne; it may be used also for plantar warts. 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
00810207784487Van Sickle38-9032026-06-30
00810207784005Van Sickle10-981NA2026-07-07
00810207784012Van Sickle10-983NA2026-07-07
00810207784029Van Sickle11-981NA2026-07-07
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

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Primary DI, Brand, Company table
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00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
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00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
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00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
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