AART Pectoralis Implant 500-101-6C

GUDID B4905001016C0

Pectoral Sty 1 Sz 1 R Sterile

Aart

Pectoral implant, sterile

• Primary Device ID: B4905001016C0
• NIH Device Record Key: 61f9010b-f681-46d4-92e3-7c421c7178c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Pectoralis Implant
• Version Model Number: C
• Catalog Number: 500-101-6C
• Company DUNS: 091356894
• Company Name: Aart
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4905001016C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021337

FDA Product Code

• MIC: Implant, muscle, pectoralis

Sterilization

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

[B4905001016C0]

Dry Heat Sterilization

[B4905001016C0]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

On-Brand Devices [AART Pectoralis Implant]

• B4905004046A0: Pectoral Sty 4 Sz 4 R Sterile
• B4905004045A0: Pectoral Sty 4 Sz 4 L Sterile
• B4905004036A0: Pectoral Sty 4 Sz 3 R Sterile
• B4905004035A0: Pectoral Sty 4 Sz 3 L Sterile
• B4905004026A0: Pectoral Sty 4 Sz 2 R Sterile
• B4905004025A0: Pectoral Sty 4 Sz 2 L Sterile
• B4905004016A0: Pectoral Sty 4 Sz 1 R Sterile
• B4905004015A0: Pectoral Sty 4 Sz 1 L Sterile
• B4905003026D0: Pectoral Sty 3 Sz 2 R Sterile
• B4905003025D0: Pectoral Sty 3 Sz 2 L Sterile
• B4905003016D0: Pectoral Sty 3 Sz 1 R Sterile
• B4905003015D0: Pectoral Sty 3 Sz 1 L Sterile
• B4905002036B0: Pectoral Sty 2 Sz 3 R Sterile
• B4905002035B0: Pectoral Sty 2 Sz 3 L Sterile
• B49050020359B0: Pectoral Sty 2 Sz 3 L w/ ST Sterile
• B49050020359A0: Pectoral Sty 2 Sz 3 L w/ ST Sterile
• B4905002026B0: Pectoral Sty 2 Sz 2 R Sterile
• B4905002025B0: Pectoral Sty 2 Sz 2 L Sterile
• B4905002016B0: Pectoral Sty 2 Sz 1 R Sterile
• B49050020169B0: Pectoral Sty 2 Sz 1 R w/ BL/ST Sterile
• B49050020169A0: Pectoral Sty 2 Sz 1 R w/ BL/ST Sterile
• B4905002015B0: Pectoral Sty 2 Sz 1 L Sterile
• B49050020159B0: Pectoral Sty 2 Sz 1 L w/ BL/ST Sterile
• B49050020159A0: Pectoral Sty 2 Sz 1 L w/ BL/ST Sterile
• B4905002006A0: Pectoral Sty 2 Sz 0 R Sterile
• B4905002005A0: Pectoral Sty 2 Sz 0 L Sterile
• B4905001066A0: Pectoral Sty 1 Sz 6 R Sterile
• B4905001065A0: Pectoral Sty 1 Sz 6 L Sterile
• B4905001056A0: Pectoral Sty 1 Sz 5 R Sterile
• B4905001055A0: Pectoral Sty 1 Sz 5 L Sterile
• B4905001046A0: Pectoral Sty 1 Sz 4 R Sterile
• B4905001045A0: Pectoral Sty 1 Sz 4 L Sterile
• B4905001036C0: Pectoral Sty 1 Sz 3 R Sterile
• B4905001035C0: Pectoral Sty 1 Sz 3 L Sterile
• B4905001026C0: Pectoral Sty 1 Sz 2 R Sterile
• B4905001025C0: Pectoral Sty 1 Sz 2 L Sterile
• B4905001016C0: Pectoral Sty 1 Sz 1 R Sterile
• B4905001015C0: Pectoral Sty 1 Sz 1 L Sterile