FDA.reportPublic FDA data

PACK-EVOSKIN

Primary DI
03760173235216
Brand
PACK-EVOSKIN
Company
AESTHETIC GROUP
Model
1
Published
2024-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTNPlastic Surgery And Accessories Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760173235223PackageGS18In Commercial Distribution
03760173235216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760173235223037601732352233760173235223
03760173235216037601732352163760173235216

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/injection setA collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260069352
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760173236206FAT HARVESTING CANNULACP32812HR2026-03-18
03760173236213FAT HARVESTING CANNULACP42812HR2026-03-18
03760173235339PACK LIPOFILLING MACROGRAFTPACK-MALT2026-02-04
03760173235360PACK LIPOFILLING MEDIUMGRAFTPACK-MELT2026-02-04
03760173235346PACK LIPOFILLING MACROGRAFTPACK-MALT2026-02-04
03760173235377PACK LIPOFILLING MEDIUMGRAFTPACK-MELT2026-02-04
03760173235391PACK LIPOFILLING MICROGRAFTPACK-MILT2026-02-04
03760173235421PACK LIPOFILLING NANOGRAFTPACK-NALT2026-02-04
03701068808054Kit lipofilling facePACK0002025-10-13
03701068808146Kit lipofilling facePACK-GOLD2020-12-14
03760173233694Infiltration kit1PACK001-BI2021-08-15
03760173235292DISPOSABLE FAT HARVESTING CANNULA8-hole Arthrex labellingCP141508H2024-12-09
03701068800829DISPOSABLE TUMESCENT INFILTRATION CANNULA10-holeCI252502022-04-29
03701068803233DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT1-holeKIT29/L2022-04-30
03701068804063DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2525KR2022-04-29
03701068804094DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2538KR2022-04-29
03701068804124DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2725KR2022-04-29
03701068804155DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI2750KR2022-04-30
03701068804186DISPOSABLE MICRO CANNULA FOR FILLER INJECTION1-holeMI3025KR2022-04-30
03701068805305DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT1-holeMI2170KS2022-04-30

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