Kit lipofilling face

GUDID 03701068808153

Kit lipofilling face

AESTHETIC GROUP

Autologous adipose tissue collection/injection set

Primary Device ID	03701068808153
NIH Device Record Key	3682e3f0-c74c-4275-9d52-dfe7d75a67bb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Kit lipofilling face
Version Model Number	PACK-GOLD
Company DUNS	260069352
Company Name	AESTHETIC GROUP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701068808146 [Primary]
GS1	03701068808153 [Package] Contains: 03701068808146 Package: box [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132353

FDA Product Code

FTN	Plastic Surgery And Accessories Kit
MUU	System, Suction, Lipoplasty

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-12-22
Device Publish Date	2020-12-14

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03701068800812 - DISPOSABLE TUMESCENT INFILTRATION CANNULA	2022-05-09 2,5mm x 25 cm - 10-hole
03701068803042 - DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT	2022-05-09 18gauge x 11 cm - 1-hole
03701068804070 - DISPOSABLE MICRO CANNULA FOR FILLER INJECTION	2022-05-09 25gauge x 2,5 cm - 1-hole
03701068804100 - DISPOSABLE MICRO CANNULA FOR FILLER INJECTION	2022-05-09 25gauge x 3,8 cm - 1-hole
03701068804131 - DISPOSABLE MICRO CANNULA FOR FILLER INJECTION	2022-05-09 27gauge x 2,5 cm - 1-hole
03701068804162 - DISPOSABLE MICRO CANNULA FOR FILLER INJECTION	2022-05-09 27gauge x 5 cm - 1-hole