AART Silicone Sheeting 200-33-05B

GUDID B4902003305B1

Silicone Sheeting, 3"x3"x.005 NR Sterile

Aart

Silicone-sheet tissue reconstructive material, sterile

• Primary Device ID: B4902003305B1
• NIH Device Record Key: b1946927-3df6-4e57-acf4-7533235e7d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Silicone Sheeting
• Version Model Number: B
• Catalog Number: 200-33-05B
• Company DUNS: 091356894
• Company Name: Aart
• Device Count: 5
• 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
• 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	B4902003305B0 [Unit of Use]
HIBCC	B4902003305B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022223

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 Silicone Sheeting]

• B4902016640B0: Silicone Sheeting, 6"x6"x.040 R Sterile
• B4902016640A0: Silicone Sheeting, 6"x6"x.040 R Sterile
• B49020166408A0: Silicone Sheeting, 6"x6"x.040 R NS
• B4902016630A0: Silicone Sheeting, 6"x6"x.030 R Sterile
• B49020166308A0: Silicone Sheeting, 6"x6"x.030 R NS
• B4902016620A0: Silicone Sheeting, 6"x6"x.020 R Sterile
• B49020166208A0: Silicone Sheeting, 6"x6"x.020 R NS
• B4902016610A0: Silicone Sheeting, 6"x6"x.010 R Sterile
• B49020166108A0: Silicone Sheeting, 6"x6"x.010 R NS
• B4902013340B1: Silicone Sheeting, 3"x3"x.040 R Sterile
• B4902013330A1: Silicone Sheeting, 3"x3"x.030 R Sterile
• B4902013320A1: Silicone Sheeting, 3"x3"x.020 R Sterile
• B4902013310A1: Silicone Sheeting, 3"x3"x.010 R Sterile
• B4902011240B0: Silicone Sheeting,12"x12"x.040 R Sterile
• B4902011230B0: Silicone Sheeting,12"x12"x.030 R Sterile
• B4902011220B0: Silicone Sheeting,12"x12"x.020 R Sterile
• B4902006640A0: Silicone Sheeting, 6"x6"x.040 NR Sterile
• B49020066408A0: Silicone Sheeting, 6"x6"x.040 NR NS
• B4902006630A0: Silicone Sheeting, 6"x6"x.030 NR Sterile
• B49020066308A0: Silicone Sheeting, 6"x6"x.030 NR NS
• B4902006620A0: Silicone Sheeting, 6"x6"x.020 NR Sterile
• B49020066208A0: Silicone Sheeting, 6"x6"x.020 NR NS
• B4902006610A0: Silicone Sheeting, 6"x6"x.010 NR Sterile
• B49020066108A0: Silicone Sheeting, 6"x6"x.010 NR NS
• B4902006605B0: Silicone Sheeting, 6"x6"x.005 NR Sterile
• B4902006605A0: Silicone Sheeting, 6"x6"x.005 NR Sterile
• B49020066058A0: Silicone Sheeting, 6"x6"x.005 NR NS
• B4902003340A1: Silicone Sheeting, 3"x3"x.040 NR Sterile
• B4902003330A1: Silicone Sheeting, 3"x3"x.030 NR Sterile
• B4902003320B1: Silicone Sheeting, 3"x3"x.020 NR Sterile
• B4902003310B1: Silicone Sheeting, 3"x3"x.010 NR Sterile
• B4902003305B1: Silicone Sheeting, 3"x3"x.005 NR Sterile
• B4902001205A0: Silicone Sheeting,12"x12"x.005 NR Sterile