FDA.reportPublic FDA data

Eclipse Cosmetic Applicator Kit

Primary DI
00853602008192
Brand
Eclipse Cosmetic Applicator Kit
Company
ECLIPSE
Model
MP1002-CA-K12GF
Catalog number
MP1002-CA-K12GF
Device description
Cosmetic Applicator Kit GF - includes a sterile, disposable cartridge tip, MicroGlide GF (topical serum), and a disposable sleeve.
Published
2018-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853602008192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853602008192008536020081928536020081920853602008192

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needle cartridgeA sterile 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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth4.5Inch
Height4.375Inch
Weight347.1Gram
Width6.25Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969752364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853602008185Eclipse MicroPen EliteMP1001-IISilverMP1001-IISilver2018-10-04
00853602008390Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
00853602008598Eclipse MicroPen EVO50EVO1000-01050EVO1000-0102022-01-11
00853602008406Eclipse MicroPen Elite Turbo Safety CartridgeMPE1002MS-KitMPE1002MS-Kit2019-05-03
00853602008208Eclipse Cosmetic Applicator KitMP1002-CA-K12HAMP1002-CA-K12HA2018-10-04
00853602008215Eclipse Cosmetic Applicator KitMP1002-CA-K1GFMP1002-CA-K1GF2018-10-04
00853602008222Eclipse Cosmetic Applicator KitMP1002-CA-K1HAMP1002-CA-K1HA2018-10-04
00853602008239Eclipse MicroPen EliteMP1002-II-K18CANMP1002-II-K18CAN2018-10-04
00853602008246Eclipse Cosmetic Applicator KitCA-100-00-01CA-100-00-012018-10-04
00853602008253Eclipse Cosmetic Applicator KitCA-100-00-02CA-100-00-022018-10-04
00853602008260Eclipse Cosmetic Applicator KitMP1002-CA-K12GF-SMP1002-CA-K12GF-S2018-10-04
00853602008338Eclipse MicroPen EliteMP1002-II-K12HAMP1002-II-K12HA2018-10-04
00853602008345Eclipse MicroPen EliteMP1002-II-K12GFMP1002-II-K12GF2018-10-04
00853602008352Eclipse MicroPen EliteMP1002-II-12MP1002-II-122018-10-04
00853602008369Eclipse MicroPen EliteMP1002-II-K12MP1002-II-K122018-10-04
00853602008376Eclipse MicroPen EliteMP1002-CA-K12HA-SMP1002-CA-K12HA-S2018-10-04
10853602008397Eclipse EVO Microneedling Cartridge50EVO2000-01050EVO2000-0102022-01-11
00853602008604Eclipse Hypodermic Needle - 18G50PRP2500-N18gx25mm2022-01-11
00853602008611Eclipse Hypodermic Needle - 30G50PRP2500-N30gx13mm50PRP2500-N30gx13mm2022-01-11
00853602008079Eclipse PRP HC PRP2000PRP20002018-10-04