Dermapose Access

GUDID 10863445000366

PUREGRAFT LLC

Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set Autologous adipose tissue collection/injection set

• Primary Device ID: 10863445000366
• NIH Device Record Key: f20284e0-aa85-4eeb-9751-980640a3db90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermapose Access
• Version Model Number: ACCESS
• Company DUNS: 079508934
• Company Name: PUREGRAFT LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep package dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863445000369 [Primary]
GS1	10863445000366 [Package]; Contains: 00863445000369; Package: Case [18 Units]; In Commercial Distribution

FDA Product Code

• MUU: System, Suction, Lipoplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-22
• Device Publish Date: 2020-08-24

Devices Manufactured by PUREGRAFT LLC

• 00850009190130 - AutoPose Restore: 2023-01-12 A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat
• 10863445000359 - Dermapose Refresh: 2021-11-22
• 10863445000366 - Dermapose Access: 2021-11-22
• 10863445000366 - Dermapose Access: 2021-11-22
• 00860407002287 - Puregraft MicroFat Transfer Kit (19G): 2020-09-01
• 00860407002294 - Puregraft MicroFat Transfer Kit (21G): 2020-09-01
• 00860407002232 - Dermapose Refresh Syringe Stand: 2020-08-31
• 00860407002270 - Puregraft MicroFat Transfer Kit: 2020-03-26
• 10860407002215 - Puregraft: 2019-12-16 Puregraft 250 System (Made in USA)