FDA.reportPublic FDA data

Softspan Tissue Expander

Primary DI
00812790029396
Brand
Softspan Tissue Expander
Company
Sientra, Inc.
Model
SIE-FK-127
Catalog number
SIE-FK-127
Device description
Tissue Expander, Flat Kidney, Textured Surface, Integrated Port, Reinforced Base, 140-350 cc
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCJExpander, Skin, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070303000SILICONE TISSUE EXPANDERSpecialty Surgical Products2007-06-22LCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812790029396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812790029396008127900293968127900293960812790029396

GMDN Terms#

Term, Definition table
TermDefinition
Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-708-0808customer.experience@sientra.com

Regulatory Flags#

DUNS number
010209877
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076894621Sientra Viality-1400Viality-1400Viality-14002023-03-13
00812790023196SIENTRA Nasal Implant71-060U71-060U2015-10-23
00812790023202SIENTRA Nasal Implant72-060U72-060U2015-10-23
00812790028191AlloX2 Tissue ExpanderAlloX2-FH11SEAlloX2-FH11SE2020-05-19
00812790028207AlloX2 Tissue ExpanderAlloX2-FH12SEAlloX2-FH12SE2020-05-19
00812790028214AlloX2 Tissue ExpanderAlloX2-FH13SEAlloX2-FH13SE2020-05-19
00812790028221AlloX2 Tissue ExpanderAlloX2-FH14SEAlloX2-FH14SE2020-05-19
00812790028238AlloX2 Tissue ExpanderAlloX2-FH15SEAlloX2-FH15SE2020-05-19
00812790028245AlloX2 Tissue ExpanderAlloX2-FH16SEAlloX2-FH16SE2020-05-19
00812790028252AlloX2 Tissue ExpanderAlloX2-FH11EAlloX2-FH11E2020-05-19
00812790028269AlloX2 Tissue ExpanderAlloX2-FH12EAlloX2-FH12E2020-05-19
00812790028276AlloX2 Tissue ExpanderAlloX2-FH13EAlloX2-FH13E2020-05-19
00812790028283AlloX2 Tissue ExpanderAlloX2-FH14EAlloX2-FH14E2020-05-19
00812790028290AlloX2 Tissue ExpanderAlloX2-FH15EAlloX2-FH15E2020-05-19
00812790028306AlloX2 Tissue ExpanderAlloX2-FH16EAlloX2-FH16E2020-05-19
00812790028313AlloX2 Tissue ExpanderAlloX2-12SEAlloX2-12SE2020-05-19
00812790028320AlloX2 Tissue ExpanderAlloX2-13SEAlloX2-13SE2020-05-19
00812790028337AlloX2 Tissue ExpanderAlloX2-14SEAlloX2-14SE2020-05-19
00812790028344AlloX2 Tissue ExpanderAlloX2-15SEAlloX2-15SE2020-05-19
00812790028351AlloX2 Tissue ExpanderAlloX2-16SEAlloX2-16SE2020-05-19

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