FDA.reportPublic FDA data

PACK LIPOFILLING MACROGRAFT

Primary DI
03760173235346
Brand
PACK LIPOFILLING MACROGRAFT
Company
AESTHETIC GROUP
Model
PACK-MALT
Device description
PACK LIPOFILLING MACROGRAFT
Published
2026-02-04
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760173235346PackageGS11In Commercial Distribution
03760173235339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760173235346037601732353463760173235346
03760173235339037601732353393760173235339

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue reinjection setA collection of devices which includes an invasive cannula/needle, intended for both harvesting fat tissue from a patient (liposuction) and subsequently injecting the fat tissue into the patient from whom it was taken (autologous lipotransfer) as part of a surgical procedure (e.g., reconstructive/cosmetic, orthopaedic, spinal); it may additionally be intended to process the adipose tissue. In addition to needles/cannulae, it includes syringes, accessories (e.g., caps, connectors), and may include collection/processing devices (e.g., filtration bag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260069352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
03760173236206FAT HARVESTING CANNULACP32812HR2026-03-18
03760173236213FAT HARVESTING CANNULACP42812HR2026-03-18
03760173235339PACK LIPOFILLING MACROGRAFTPACK-MALT2026-02-04
03760173235360PACK LIPOFILLING MEDIUMGRAFTPACK-MELT2026-02-04
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
03760173235216PACK-EVOSKIN12024-09-05
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