PuraPly™ Antimicrobial XT Wound Matrix
GUDID 00618474000466
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
Collagen wound matrix dressing| Primary Device ID | 00618474000466 |
| NIH Device Record Key | 8bbac236-af49-47dd-944d-323609885f4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PuraPly™ Antimicrobial XT Wound Matrix |
| Version Model Number | 515-017 |
| Company DUNS | 152165817 |
| Company Name | ORGANOGENESIS 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM | |
| Phone | 1-888-432-5232 |
| MEDINFO@ORGANO.COM |
Device Dimensions
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
| Width | 4.91 Centimeter |
| Length | 4.91 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618474000466 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051647
FDA Product Code
| FRO | Dressing, Wound, Drug |
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 | 2021-12-09 |
| Device Publish Date | 2021-12-01 |
On-Brand Devices [PuraPly™ Antimicrobial XT Wound Matrix]
| 00618474000275 | PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam |
| 00061874000282 | PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam |
| 00618474000282 | PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam |
| 00618474000466 | PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexam |
Trademark Results [PuraPly]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURAPLY 86512814 4942534 Live/Registered |
Organogenesis Inc. 2015-01-23 |
 PURAPLY 78058906 2637413 Dead/Cancelled |
Organogenesis, Inc. 2001-04-17 |
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