FDA.reportPublic FDA data

Comedone Extractor

Primary DI
00192896118171
Brand
Comedone Extractor
Company
SONTEC INSTRUMENTS, INC.
Model
199-160T
Catalog number
199-160T
Device description
Comedone Extractor Double End Fenestrated Curved Cup/Straight Lancet Titanium
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00192896118171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896118171001928961181711928961181710192896118171

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.75Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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