NovoSorb MTX
GUDID 09349155001359
NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.
POLYNOVO BIOMATERIALS PTY LIMITED
Synthetic wound matrix dressing| Primary Device ID | 09349155001359 |
| NIH Device Record Key | edfff03d-c1df-4ac6-98e2-fab650e98f88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovoSorb MTX |
| Version Model Number | MTX-2040 |
| Company DUNS | 752326723 |
| Company Name | POLYNOVO BIOMATERIALS PTY LIMITED |
| 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com | |
| Phone | +1-760-448-5515 |
| info@polynovo.com |
Device Dimensions
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
| Width | 40 Centimeter |
| Length | 20 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349155001342 [Primary] |
| GS1 | 09349155001359 [Package] Contains: 09349155001342 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 09349155001366 [Package] Package: Carton [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221686
FDA Product Code
| QSZ | Absorbable Synthetic Wound Dressing |
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 | 2023-10-05 |
| Device Publish Date | 2023-09-27 |
On-Brand Devices [NovoSorb MTX]
| 09349155001328 | NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging |
| 09349155001298 | NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging |
| 09349155001359 | NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging |
| 09349155002608 | NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging |
Trademark Results [NovoSorb MTX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVOSORB MTX 97683370 not registered Live/Pending |
PolyNovo Biomaterials Pty Limited 2022-11-18 |
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