PuraPly™ Antimicrobial Wound Matrix
GUDID 00618474000435
PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
ORGANOGENESIS INC.
Collagen wound matrix dressing| Primary Device ID | 00618474000435 |
| NIH Device Record Key | a9244a5d-ed35-400a-a563-9bcfc6e4a9e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PuraPly™ Antimicrobial Wound Matrix |
| Version Model Number | 515-065 |
| 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 | true |
| 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 | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com | |
| Phone | 1-888-432-5232 |
| xx@xx.com |
Device Dimensions
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 Centimeter |
| Length | 3 Centimeter |
| Width | 4 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618474000435 [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 | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
On-Brand Devices [PuraPly™ Antimicrobial Wound Matrix]
| 00618474000121 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000114 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000107 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000091 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000084 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000039 | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene |
| 00618474000435 | PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb |
| 00618474000459 | PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb |
| 00618474000442 | uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with poly |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.