Puracyn® Plus Professional Formula
GUDID 10818582011805
Innovacyn, Inc.
Wound hydrogel dressing, antimicrobial| Primary Device ID | 10818582011805 |
| NIH Device Record Key | 22baa5d2-d457-40f3-b3e3-d5bbe4f94131 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Puracyn® Plus Professional Formula |
| Version Model Number | 6542 |
| Company DUNS | 025217003 |
| Company Name | Innovacyn, 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com | |
| Phone | 866-787-2296 |
| customerservice@innovacyn.com |
Device Dimensions
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
| Total Volume | 90 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818582011808 [Primary] |
| GS1 | 10818582011805 [Package] Contains: 00818582011808 Package: Box [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150799
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-27 |
| Device Publish Date | 2022-10-19 |
On-Brand Devices [Puracyn® Plus Professional Formula ]
| 10818582010853 | 6502 |
| 10818582011010 | 6509 |
| 10818582011003 | 6505 |
| 10818582010990 | 6503 |
| 10818582010785 | 6508 |
| 10818582010761 | 6504 |
| 10818582012789 | 6549 |
| 10818582011805 | 6542 |
| 10818582011720 | 6518 |
| 10818582011331 | 6527 |
| 10818582011324 | 6525 |
| 10818582011317 | 6524 |
| 10818582011027 | 6517 |
| 10818582010778 | 6516 |
Trademark Results [Puracyn]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURACYN 85494465 4183320 Live/Registered |
Innovacyn, Inc. 2011-12-13 |
 PURACYN 85014934 3896754 Live/Registered |
INNOVACYN, INC. 2010-04-15 |
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