FDA.reportPublic FDA data

XSONX

Primary DI
00850051554003
Brand
XSONX
Company
XSONX LLC
Model
Rev. B
Catalog number
100 001 5
Device description
Handpiece 1.0
Published
2026-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850051554000PackageGS11In Commercial Distribution
00850051554003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005155400010850051554000
00850051554003008500515540038500515540030850051554003

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held sonic wound scrubbing/debridement system handpieceA hand-held, electrically-powered component of a sonic wound scrubbing/debridement system intended to generate low frequency (below 20 kHz) vibrations for wound scrubbing or debridement in conjunction with a removable tip (not included). Often referred to as a wound therapy device, it is primarily intended to treat hard-to-heal open wounds (e.g., acute, traumatic, chronic). This is a reusable device.

Regulatory Flags#

DUNS number
066490865
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Company table
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