ProgenaMatrix
GUDID 00850017159020
Human Keratin Matrix
Progenacare Global, LLC
Collagen wound matrix dressing| Primary Device ID | 00850017159020 |
| NIH Device Record Key | 4fcc8cf2-2228-4b4c-bcf4-db0f6bb6b7eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProgenaMatrix |
| Version Model Number | PM3002 |
| Company DUNS | 054791028 |
| Company Name | Progenacare Global, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com | |
| Phone | 770-627-2547 |
| s.gray@progenacare.com |
Device Dimensions
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
| Length | 2 Centimeter |
| Width | 2 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017159020 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182010
FDA Product Code
| KGN | Dressing, Wound, Collagen |
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 | 2022-04-15 |
| Device Publish Date | 2022-04-07 |
On-Brand Devices [ProgenaMatrix]
| 00850017159129 | Human Keratin Matrix |
| 00850017159105 | Human Keratin Matrix |
| 00850017159068 | Human Keratin Matrix |
| 00850017159044 | Human Keratin Matrix |
| 00850017159020 | Human Keratin Matrix |
| 00850017159013 | Human Keratin Matrix |
Trademark Results [ProgenaMatrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGENAMATRIX 87361002 5571432 Live/Registered |
Cell Constructs I, LLC 2017-03-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.