FDA.reportPublic FDA data

SP MicroPen EVO Microneedling Cartridge

Primary DI
00850035498279
Brand
SP MicroPen EVO Microneedling Cartridge
Company
Bellus Medical, LLC
Model
F5SP223
Device description
MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use.
Published
2022-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035498293PackageGS11In Commercial Distribution
00850035498323PackageGS11In Commercial Distribution
00850035498330PackageGS12In Commercial Distribution
00850035498804PackageGS12In Commercial Distribution
00850035498835PackageGS12In Commercial Distribution
00850035498842PackageGS11In Commercial Distribution
00850035498859PackageGS11In Commercial Distribution
00850035498880PackageGS11In Commercial Distribution
00850035498897PackageGS11In Commercial Distribution
00850060751295PackageGS11In Commercial Distribution
00850060751912PackageGS112In Commercial Distribution
10850035498290PackageGS112In Commercial Distribution
00850035498279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035498293008500354982938500354982930850035498293
00850035498323008500354983238500354983230850035498323
00850035498330008500354983308500354983300850035498330
00850035498804008500354988048500354988040850035498804
00850035498835008500354988358500354988350850035498835
00850035498842008500354988428500354988420850035498842
00850035498859008500354988598500354988590850035498859
00850035498880008500354988808500354988800850035498880
00850035498897008500354988978500354988970850035498897
00850060751295008500607512958500607512950850060751295
00850060751912008500607519128500607519120850060751912
1085003549829010850035498290
00850035498279008500354982798500354982790850035498279

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece cartridge, professionalA device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888.372.3982customerservice@crownaesthetics.com

Regulatory Flags#

DUNS number
005677967
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060751028SkinPen Precision EliteREF015F5SP3882024-10-01
00850060751738SkinPenF5SP5812026-05-20
00863221000309SkinPen Precision CartridgeREF014F5SP0212018-04-09
00850060751110ProGen PRP EclipseP5PG052PROGEN-A152024-08-28
00850060751158ProGen PRP EclipseP5PG053PROGEN-A302024-08-28
00863221000323SkinPen Precision Treatment KitF5SP013F5SP0132018-04-09
00850060751004SkinPen Precision EliteREF200F5SP386, F5SP4182024-10-01
00850060751011SkinPen Precision EliteREF201F5SP387, F5SP419, F5SP4542024-10-01
00850060751103ProGen PRP EclipseP5PG0192024-08-28
00850060751141ProGen PRP EclipseP5PG0202024-08-28
00850035498262SP MicroPen EVOF5SP2162022-05-25
00850035498378Progen PRP EclipseTN15MLSINGLEF5PG013.022022-05-09
00850035498385Progen PRP EclipseTN30MLSINGLEF5PG014.022022-05-09
00850060751035SkinPen Precision EliteREF200/REF201F5SP3892024-10-01
00850035498873SkinPen Precision Premium Treatment KitF5SP391F5SP3912023-07-31
00850035498415Progen PRP EclipseF5PG0172022-04-22
00850035498422Progen PRP EclipseF5PG0182022-04-22
00850035498439Progen PRP EclipseF5PG0192022-04-22
00850035498446Progen PRP EclipseF5PG0202022-04-22
10863221000320SkinPen Precision Treatment Kits1F5SP0182018-04-09

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Primary DI, Brand, Company table
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