AART Silicone Sheeting 201-33-10A

GUDID B4902013310A1

Silicone Sheeting, 3"x3"x.010 R Sterile

Aart

Silicone-sheet tissue reconstructive material, sterile Silicone-sheet tissue reconstructive material, sterile Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material Silicone-sheet tissue reconstructive material
Primary Device IDB4902013310A1
NIH Device Record Keyf16b2c3a-7dc8-4634-b2b3-74383dffe72f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAART Silicone Sheeting
Version Model NumberA
Catalog Number201-33-10A
Company DUNS091356894
Company NameAart
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net
Phone+1(775)853-6800
Emailcustomer.service@aartinc.net

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB4902013310A0 [Unit of Use]
HIBCCB4902013310A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBELASTOMER, SILICONE BLOCK

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-20

On-Brand Devices [AART Silicone Sheeting]

B4902016640B0Silicone Sheeting, 6"x6"x.040 R Sterile
B4902016640A0Silicone Sheeting, 6"x6"x.040 R Sterile
B49020166408A0Silicone Sheeting, 6"x6"x.040 R NS
B4902016630A0Silicone Sheeting, 6"x6"x.030 R Sterile
B49020166308A0Silicone Sheeting, 6"x6"x.030 R NS
B4902016620A0Silicone Sheeting, 6"x6"x.020 R Sterile
B49020166208A0Silicone Sheeting, 6"x6"x.020 R NS
B4902016610A0Silicone Sheeting, 6"x6"x.010 R Sterile
B49020166108A0Silicone Sheeting, 6"x6"x.010 R NS
B4902013340B1Silicone Sheeting, 3"x3"x.040 R Sterile
B4902013330A1Silicone Sheeting, 3"x3"x.030 R Sterile
B4902013320A1Silicone Sheeting, 3"x3"x.020 R Sterile
B4902013310A1Silicone Sheeting, 3"x3"x.010 R Sterile
B4902011240B0Silicone Sheeting,12"x12"x.040 R Sterile
B4902011230B0Silicone Sheeting,12"x12"x.030 R Sterile
B4902011220B0Silicone Sheeting,12"x12"x.020 R Sterile
B4902006640A0Silicone Sheeting, 6"x6"x.040 NR Sterile
B49020066408A0Silicone Sheeting, 6"x6"x.040 NR NS
B4902006630A0Silicone Sheeting, 6"x6"x.030 NR Sterile
B49020066308A0Silicone Sheeting, 6"x6"x.030 NR NS
B4902006620A0Silicone Sheeting, 6"x6"x.020 NR Sterile
B49020066208A0Silicone Sheeting, 6"x6"x.020 NR NS
B4902006610A0Silicone Sheeting, 6"x6"x.010 NR Sterile
B49020066108A0Silicone Sheeting, 6"x6"x.010 NR NS
B4902006605B0Silicone Sheeting, 6"x6"x.005 NR Sterile
B4902006605A0Silicone Sheeting, 6"x6"x.005 NR Sterile
B49020066058A0Silicone Sheeting, 6"x6"x.005 NR NS
B4902003340A1Silicone Sheeting, 3"x3"x.040 NR Sterile
B4902003330A1Silicone Sheeting, 3"x3"x.030 NR Sterile
B4902003320B1Silicone Sheeting, 3"x3"x.020 NR Sterile
B4902003310B1Silicone Sheeting, 3"x3"x.010 NR Sterile
B4902003305B1Silicone Sheeting, 3"x3"x.005 NR Sterile
B4902001205A0Silicone Sheeting,12"x12"x.005 NR Sterile
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.