AART Calf Implant Sizer 502-301-2E

GUDID B4905023012E0

Szr - Calf Sty 3 Sz 1 NS

Aart

Silicone-block tissue reconstructive material

• Primary Device ID: B4905023012E0
• NIH Device Record Key: 83134a0e-2e27-42aa-ac05-c1c3cc9c1b2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Calf Implant Sizer
• Version Model Number: E
• Catalog Number: 502-301-2E
• 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
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• 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	B4905023012E0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022511

FDA Product Code

• MIB: ELASTOMER, SILICONE BLOCK

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

On-Brand Devices [AART Calf Implant Sizer]

• B4905023092E0: Szr - Calf Sty 3 Sz 9 NS
• B4905023082E0: Szr - Calf Sty 3 Sz 8 NS
• B4905023072E0: Szr - Calf Sty 3 Sz 7 NS
• B4905023062E0: Szr - Calf Sty 3 Sz 6 NS
• B4905023052E0: Szr - Calf Sty 3 Sz 5 NS
• B4905023042E0: Szr - Calf Sty 3 Sz 4 NS
• B4905023032E0: Szr - Calf Sty 3 Sz 3 NS
• B4905023022E0: Szr - Calf Sty 3 Sz 2 NS
• B4905023012E0: Szr - Calf Sty 3 Sz 1 NS
• B4905023002E0: Szr - Calf Sty 3 Sz 0 NS
• B4905022022C0: Szr - Calf Sty 2 Sz 2 NS
• B4905022012C0: Szr - Calf Sty 2 Sz 1 NS
• B4905021072A0: Szr - Calf Sty 1 Sz 7 NS
• B4905021062A0: Szr - Calf Sty 1 Sz 6 NS
• B4905021052C0: Szr - Calf Sty 1 Sz 5 NS
• B4905021042C0: Szr - Calf Sty 1 Sz 4 NS
• B4905021032C0: Szr - Calf Sty 1 Sz 3 NS
• B49050210321A0: Szr - Calf Sty 1 Sz 3 Sterile
• B4905021022C0: Szr - Calf Sty 1 Sz 2 NS
• B4905021012C0: Szr - Calf Sty 1 Sz 1 NS