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 Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing 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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