TIGR® Matrix Surgical Mesh

Primary DI
07332999000093
Brand
TIGR® Matrix Surgical Mesh
Company
Novus Scientific AB
Model
NSTM1520
Catalog number
NSTM1520
Published
2015-09-24
Public version status
Update
Distribution status
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
FTLMesh, Surgical, Polymeric
OWTMesh, Surgical, Absorbable, Abdominal Hernia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092224000
K163005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092224000TIGR SURGICAL MESH , MODEL WK-6Novus Scientific Pte, Ltd.2010-01-25FTL
K163005000TIGR Matrix Surgical MeshNovus Scientific AB2017-07-27OWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332999000093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332999000093073329990000937332999000093

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbableA sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Width15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46187001150info@novusscientific.com

Regulatory Flags#

DUNS number
776732898
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332999000222TIGR® Matrix Surgical MeshNSTM1015NSTM10152025-08-29
07332999000239TIGR® Matrix Surgical MeshNSTM1520NSTM15202025-08-29
07332999000246TIGR® Matrix Surgical MeshNSTM2030NSTM20302025-08-29
07332999000468TIGR® Matrix Surgical MeshNSTMR17NSTMR172025-08-29
07332999000475TIGR® Matrix Surgical MeshNSTMR20NSTMR202025-08-29
07332999000017TIGR® Matrix Surgical MeshNSTM1015NSTM10152015-09-24
07332999000024TIGR® Matrix Surgical MeshNSTM2030NSTM20302015-09-24

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