Softspan Tissue Expander SRE-CV-720S

GUDID 00812790029709

Tissue Expander, Curvilinear, Zone Textured Surface, Remote Port, Reinforced Base, 720-1080 cc

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 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 ID00812790029709
NIH Device Record Keydf15decf-0052-407b-9a9e-9acab69a0813
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftspan Tissue Expander
Version Model NumberSRE-CV-720S
Catalog NumberSRE-CV-720S
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100812790029709 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-05

On-Brand Devices [Softspan Tissue Expander]

00819409020324Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 30
00812790029570Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 500-640 cc
00819409020188Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 20-40 cc
00812790029761Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 80-200 cc
00812790029600Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 860-1020 cc
00812790029402Tissue Expander, Vu Curvilinear, Zone Textured Surface, Integrated Port, Reinforced Base, 320-48
00812790029396Tissue Expander, Flat Kidney, Textured Surface, Integrated Port, Reinforced Base, 140-350 cc
00812790029389Tissue Expander, Flat Kidney, Textured Surface, Integrated Port, Reinforced Base, 80-200 cc
00812790029259Tissue Expander, Low Rectangle, Textured Surface, Integrated Port, Reinforced Base, 160-320 cc
00812790029129Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 250-300 cc
00812790029112Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 70-90 cc
00819409020027Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Reinforced Base, 75-188 cc
00812790029280Tissue Expander, Low Rectangle, Textured Surface, Integrated Port, Reinforced Base, 340-680 cc
00819409020201Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 70-140 cc
00819409020058Tissue Expander, Vu Angle, Zone Textured Surface, Integrated Port, Reinforced Base, 450-650 cc
00812790029785Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 270-675 cc
00819409020256Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 340-680 c
00819409020171Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 750-1400 cc
00812790029419Tissue Expander, Vu Curvilinear, Zone Textured Surface, Integrated Port, Reinforced Base, 520-78
00812790029372Tissue Expander, Flat Kidney, Textured Surface, Integrated Port, Reinforced Base, 25-62 cc
00812790029709Tissue Expander, Curvilinear, Zone Textured Surface, Remote Port, Reinforced Base, 720-1080 cc
00812790029181Tissue Expander, Rectangle, Textured Surface, Remote Port, Reinforced Base, 70-90 cc
00812790029754Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 25-62 cc
00819409020249Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 250-500 c
00812790029211Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 500-600 cc
00812790029136Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 350-420 cc
00812790029549Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 320-380 cc
00812790029563Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 430-500 cc
00819409020195Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 30-60 cc
00812790029365Tissue Expander, Flat Oval, Textured Surface, Integrated Port, Reinforced Base, 60-150 cc
00812790029310Tissue Expander, Low Rectangle, Smooth Surface, Integrated Port, Reinforced Base, 200-400 cc
00819409020140Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 320-480 cc
00812790029747Tissue Expander, Flat Kidney, Textured Surface, Remote Port, Reinforced Base, 270-675 cc
00812790029730Tissue Expander, Flat Kidney, Textured Surface, Remote Port, Reinforced Base, 140-350 cc
00812790029518Tissue Expander, Round, Textured Surface, Remote Port, Reinforced Base, 860-1020 cc
00819409020072Tissue Expander, Crescent, Textured Surface, Integrated Port, Reinforced Base, 100-200 cc
00819409020041Tissue Expander, Vu Angle, Zone Textured Surface, Integrated Port, Reinforced Base, 200-300 cc
00812790029723Tissue Expander, Flat Kidney, Textured Surface, Remote Port, Reinforced Base, 80-200 cc
00812790029655Tissue Expander, Curvilinear, Zone Textured Surface, Remote Port, Reinforced Base, 320-480 cc
00819409020317Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 30
00819409020034Tissue Expander, Calf, Smooth Surface, Remote Port, Non-Reinforced Base, 500-600 cc
00812790029778Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 140-350 cc
00812790029679Tissue Expander, Curvilinear, Zone Textured Surface, Remote Port, Reinforced Base, 720-1080 cc
00819409020218Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 75-150 cc
00819409020133Tissue Expander, Crescent, Smooth Surface, Integrated Port, Reinforced Base, 350-700 cc
00812790029525Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 220-270 cc
00812790029327Tissue Expander, Low Rectangle, Smooth Surface, Integrated Port, Reinforced Base, 250-500 cc
00812790029303Tissue Expander, Low Rectangle, Smooth Surface, Integrated Port, Reinforced Base, 160-320 cc
00812790029198Tissue Expander, Rectangle, Textured Surface, Remote Port, Reinforced Base, 250-300 cc
00819409020096Tissue Expander, Crescent, Textured Surface, Integrated Port, Reinforced Base, 350-700 cc

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