TIGR® Matrix Surgical Mesh

Primary DI
07332999000468
Brand
TIGR® Matrix Surgical Mesh
Company
Novus Scientific AB
Model
NSTMR17
Catalog number
NSTMR17
Published
2025-08-29
Public version status
New
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
OODSurgical Film
OWTMesh, Surgical, Absorbable, Abdominal Hernia

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191749000TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB2020-03-26OWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332999000468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332999000468073329990004687332999000468

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter17Centimeter

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
07332999000475TIGR® Matrix Surgical MeshNSTMR20NSTMR202025-08-29
07332999000017TIGR® Matrix Surgical MeshNSTM1015NSTM10152015-09-24
07332999000024TIGR® Matrix Surgical MeshNSTM2030NSTM20302015-09-24
07332999000093TIGR® Matrix Surgical MeshNSTM1520NSTM15202015-09-24

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10801741234382GalaFLEX 3DDavol Inc.OOD2026-04-30
10801741234412GalaFLEX 3DRDavol Inc.OOD2026-04-30
10801741234436GalaFLEX 3DRDavol Inc.OOD2026-04-30
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