FDA.reportPublic FDA data

Invengenx

Primary DI
00850038226237
Brand
Invengenx
Company
Tisgenx, Inc.
Model
XM-23
Published
2025-05-28
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

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182493000Bovine Pericardial Tissue PatchTisgenx2019-06-18FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038226237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038226237008500382262378500382262370850038226237

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Centimeter
Length16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111070852
Device count
1
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038226008InvengenxXM-042025-05-28
00850038226015InvengenxXM-052025-05-28
00850038226022InvengenxXM-05T2025-05-28
00850038226039InvengenxXM-062025-05-28
00850038226046InvengenxXM-072025-05-28
00850038226053InvengenxXM-07T2025-05-28
00850038226060InvengenxXM-082025-05-28
00850038226077InvengenxXM-08T2025-05-28
00850038226084InvengenxXM-092025-05-28
00850038226091InvengenxXM-102025-05-28
00850038226107InvengenxXM-10T2025-05-28
00850038226114InvengenxXM-112025-05-28
00850038226121InvengenxXM-122025-05-28
00850038226138InvengenxXM-132025-05-28
00850038226145InvengenxXM-142025-05-28
00850038226152InvengenxXM-152025-05-28
00850038226169InvengenxXM-162025-05-28
00850038226176InvengenxXM-172025-05-28
00850038226183InvengenxXM-182025-05-28
00850038226190InvengenxXM-192025-05-28

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Primary DI, Brand, Company table
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09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTM2025-11-26
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B454VSC10VersaWrapAlafair Biosciences, Inc.FTM2024-06-10
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00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.FTM2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.FTM2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.FTM2023-05-15