NovoSorb MTX
GUDID 09349155001328
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 Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing| Primary Device ID | 09349155001328 |
| NIH Device Record Key | e7e33f93-3f00-4602-83d3-dc81b6fc7c10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovoSorb MTX |
| Version Model Number | MTX-1020 |
| 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 | |
| Phone | +1-760-448-5515 |
| info@polynovo.com |
Device Dimensions
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 Centimeter |
| Length | 20 Centimeter |
| Width | 10 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09349155001311 [Primary] |
| GS1 | 09349155001328 [Package] Contains: 09349155001311 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 09349155001335 [Package] Package: Case [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 | 2023-04-12 |
| Device Publish Date | 2023-04-04 |
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 |
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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