Invengenx

GUDID 00850038226022

Tisgenx, Inc.

Cardiovascular patch, animal-derived

• Primary Device ID: 00850038226022
• NIH Device Record Key: 5d57b28a-793d-42e2-b842-30f469f884f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invengenx
• Version Model Number: XM-05T
• Company DUNS: 111070852
• Company Name: Tisgenx, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter
• Height: 0.8 Centimeter
• Length: 8 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038226022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182493

FDA Product Code

• FTM: Mesh, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [Invengenx]

• 00850038226237: XM-23
• 00850038226220: XM-22
• 00850038226213: XM-21
• 00850038226206: XM-20
• 00850038226190: XM-19
• 00850038226183: XM-18
• 00850038226176: XM-17
• 00850038226169: XM-16
• 00850038226152: XM-15
• 00850038226145: XM-14
• 00850038226138: XM-13
• 00850038226121: XM-12
• 00850038226114: XM-11
• 00850038226107: XM-10T
• 00850038226091: XM-10
• 00850038226084: XM-09
• 00850038226077: XM-08T
• 00850038226060: XM-08
• 00850038226053: XM-07T
• 00850038226046: XM-07
• 00850038226039: XM-06
• 00850038226022: XM-05T
• 00850038226015: XM-05
• 00850038226008: XM-04