FDA.report

EXEL Dermal Curette

Primary DI
20020221295829
Brand
EXEL Dermal Curette
Company
Exel International
Model
29582
Catalog number
29582
Device description
SS, 4.0MM 50PC/BX, 6BX/CS
Published
2019-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FZSCurette, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10020221295822PackageGS150In Commercial Distribution
20020221295829PackageGS16In Commercial Distribution
00020221295825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022129582210020221295822
2002022129582920020221295829
00020221295825000202212958250202212958250020221295825

GMDN Terms

TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
8009403935info@exelint.com

Regulatory Flags

DUNS number
180572216
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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