Suprathel® 110505-US, 150505-US
GUDID 04260184021130
Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs.
Polymedics Innovations GmbH
Synthetic wound matrix dressing| Primary Device ID | 04260184021130 |
| NIH Device Record Key | 279f9a1d-691b-45e1-858c-e31481c5c21a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Suprathel® |
| Version Model Number | Suprathel 5x5 |
| Catalog Number | 110505-US, 150505-US |
| Company DUNS | 344089540 |
| Company Name | Polymedics Innovations GmbH |
| 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 | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com | |
| Phone | +1 646-604-2771 |
| info.usa@polymedics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between 8 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 22 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260184021130 [Primary] |
| GS1 | 04260184021178 [Package] Package: Carton envelope [5 Units] In Commercial Distribution |
| GS1 | 04260184021185 [Package] Package: Carton envelope [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090160
FDA Product Code
| FRO | Dressing, Wound, Drug |
| 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 | 2021-09-20 |
| Device Publish Date | 2021-09-10 |
On-Brand Devices [Suprathel®]
| 04260184021130 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
| 04260184021567 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
| 04260184021475 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
| 04260184021376 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
| 04260184021277 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
| 04260184021604 | Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treat |
Trademark Results [Suprathel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPRATHEL 79201569 5505319 Live/Registered |
PolyMedics Innovations GmbH 2016-11-07 |
 SUPRATHEL 76379337 3174424 Live/Registered |
POLYMEDICS INNOVATIONS GMBH 2002-03-07 |
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