ProgenaMatrix
GUDID 00850017159129
Human Keratin Matrix
Progenacare Global, LLC
Collagen wound matrix dressing| Primary Device ID | 00850017159129 |
| NIH Device Record Key | 86b2d566-faf2-4115-8dbb-e53c6e10e1fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProgenaMatrix |
| Version Model Number | PM2012 |
| 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 | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 Centimeter |
| Width | 2 Centimeter |
| Length | 12 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 | 00850017159129 [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 |
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