Infiltration kit PACK001-BI

GUDID 03760173233700

This kit is a convenience kit. The devices contained in the infiltration kit are used to collect fat tissue. The procedure usually involves infiltration of tumescent solution before harvesting fat tissue by liposuction.

AESTHETIC GROUP

Autologous adipose tissue collection/injection set

• Primary Device ID: 03760173233700
• NIH Device Record Key: abbcd198-4a9f-4ce3-9dc5-ba86976aa538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infiltration kit
• Version Model Number: 1
• Catalog Number: PACK001-BI
• Company DUNS: 260069352
• Company Name: AESTHETIC GROUP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760173233694 [Primary]
GS1	03760173233700 [Package]; Contains: 03760173233694; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FTN: Plastic Surgery And Accessories Kit

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: 2021-08-23
• Device Publish Date: 2021-08-15

Devices Manufactured by AESTHETIC GROUP

• 03760173235292 - DISPOSABLE FAT HARVESTING CANNULA: 2024-12-17 2,1 mm x 15 cm - 8-hole
• 03760173235216 - PACK-EVOSKIN: 2024-12-09
• 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