TELAMax 1S F10069-1822

GUDID 10856072005088

TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, provides a surface designed to minimize tissue attachment. TELAMax 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 1S is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

TELA BIO, INC.

Multi-purpose surgical mesh, biologic-polymer composite
Primary Device ID10856072005088
NIH Device Record Key66a7082e-7d49-47af-b7aa-bb69fa8584c3
Commercial Distribution Discontinuation2016-05-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTELAMax 1S
Version Model NumberF10069-1822
Catalog NumberF10069-1822
Company DUNS078721472
Company NameTELA BIO, 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 Batchtrue
Serial Numberfalse
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

Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com
Phone(844) 835-2246
Emailcustomerservice@telabio.com

Device Dimensions

Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter
Length22 Centimeter
Width18 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110856072005088 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-06
Device Publish Date2015-09-17

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