SIENTRA Tissue Expander 819-600U

GUDID 00812790022816

Tissue Expander, Rectangular, Magnetic Valve, Smooth, 600 ml

Sientra, Inc.

Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander Skin-port tissue expander
Primary Device ID00812790022816
NIH Device Record Key025ae5a9-17a9-4cb5-80b0-7d6e79926bb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Tissue Expander
Version Model Number819-600U
Catalog Number819-600U
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Dimensions

Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter
Total Volume600 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812790022816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCJExpander, Skin, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-10-23

On-Brand Devices [SIENTRA Tissue Expander]

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00812790025046Tissue Expander, Crescent, Magnetic Valve, Textured, 400 ml
00812790025039Tissue Expander, Crescent, Magnetic Valve, Textured, 300 ml
00812790025022Tissue Expander, Crescent, Magnetic Valve, Textured, 200 ml
00812790025015Tissue Expander, Crescent, Magnetic Valve, Textured, 150 ml
00812790022861Tissue Expander, Rectangular, Magnetic Valve, Smooth, 1000 ml
00812790022854Tissue Expander, Rectangular, Magnetic Valve, Smooth, 800 ml
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00812790022830Tissue Expander, Rectangular, Magnetic Valve, Smooth, 700 ml
00812790022823Tissue Expander, Rectangular, Magnetic Valve, Smooth, 640 ml
00812790022816Tissue Expander, Rectangular, Magnetic Valve, Smooth, 600 ml
00812790022809Tissue Expander, Rectangular, Magnetic Valve, Smooth, 500 ml
00812790022793Tissue Expander, Rectangular, Magnetic Valve, Smooth, 400 ml
00812790022786Tissue Expander, Rectangular, Magnetic Valve, Smooth, 320 ml
00812790022779Tissue Expander, Rectangular, Magnetic Valve, Smooth, 250 ml
00812790022762Tissue Expander, Rectangular, Magnetic Valve, Smooth, 205 ml
00812790022755Tissue Expander, Rectangular, Magnetic Valve, Smooth, 200 ml
00812790022748Tissue Expander, Rectangular, Magnetic Valve, Smooth, 160 ml
00812790022731Tissue Expander, Rectangular, 3-Valves, Smooth, 1000 ml
00812790022724Tissue Expander, Rectangular, 3-Valves, Smooth, 800 ml
00812790022717Tissue Expander, Rectangular, 3-Valves, Smooth, 720 ml
00812790022700Tissue Expander, Rectangular, 3-Valves, Smooth, 700 ml
00812790022694Tissue Expander, Rectangular, 3-Valves, Smooth, 640 ml
00812790022687Tissue Expander, Rectangular, 3-Valves, Smooth, 600 ml
00812790022670Tissue Expander, Rectangular, 3-Valves, Smooth, 500 ml
00812790022663Tissue Expander, Rectangular, 3-Valves, Smooth, 400 ml
00812790022656Tissue Expander, Rectangular, 3-Valves, Smooth, 320 ml
00812790022649Tissue Expander, Rectangular, 3-Valves, Smooth, 250 ml
00812790022632Tissue Expander, Rectangular, 3-Valves, Smooth, 205 ml
00812790022625Tissue Expander, Rectangular, 3-Valves, Smooth, 200 ml
00812790022618Tissue Expander, Rectangular, 3-Valves, Smooth, 160 ml
00812790022601Tissue Expander, Rectangular, 3-Valves, Smooth, 105 ml
00812790022595Tissue Expander, Rectangular, 3-Valves, Smooth, 100 ml
00812790022588Tissue Expander, Rectangular, 3-Valves, Smooth, 50 ml
00812790022571Tissue Expander, Rectangular, 3-Valves, Smooth, 30 ml
00812790022564Tissue Expander, Calf, 1-Valve, Smooth, 185 ml
00812790022557Tissue Expander, Calf, 1-Valve, Smooth, 145 ml
00812790022540Tissue Expander, Crescent, Magnetic Valve, Smooth, 700 ml
00812790022533Tissue Expander, Crescent, Magnetic Valve, Smooth, 400 ml
00812790022526Tissue Expander, Crescent, Magnetic Valve, Smooth, 300 ml
00812790022519Tissue Expander, Crescent, Magnetic Valve, Smooth, 200 ml
00812790022502Tissue Expander, Crescent, Magnetic Valve, Smooth, 150 ml
00812790022496Tissue Expander, Crescent, 3-Valves, Smooth, 700 ml
00812790022489Tissue Expander, Crescent, 3-Valves, Smooth, 400 ml
00812790022472Tissue Expander, Crescent, 3-Valves, Smooth, 300 ml
00812790022465Tissue Expander, Crescent, 3-Valves, Smooth, 200 ml
00812790022458Tissue Expander, Crescent, 3-Valves, Smooth, 150 ml
00812790022441Tissue Expander, Crescent, 3-Valves, Smooth, 100 ml
00812790022434Tissue Expander, Crescent, 3-Valves, Smooth, 50 ml
00812790022427Tissue Expander, Crescent, 3-Valves, Smooth, 25 ml

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