FDA.reportPublic FDA data

TELAMax

Primary DI
10856072005026
Brand
TELAMax
Company
TELA BIO, INC.
Model
F10068-1010
Catalog number
F10068-1010
Device description
TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 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.
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856072005026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085607200502610856072005026

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, biologic-polymer compositeA sterile, flat or three-dimensional (3-D) implantable material comprised of both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for multiple defective tissue repair applications at different anatomical zones (e.g., breast, cardiac, abdominal) that includes an extra-abdominal application(s) [e.g., cardiac, plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 835-2246customerservice@telabio.com

Regulatory Flags#

DUNS number
078721472
Device count
1
Lot or batch
true
Expiration date on label
true

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