ProgenaMatrix
GUDID 00850017159044
Human Keratin Matrix
Progenacare Global, LLC
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 Collagen wound matrix dressing| Primary Device ID | 00850017159044 |
| NIH Device Record Key | cb2e4074-e035-414e-94c7-32e780bd5c1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProgenaMatrix |
| Version Model Number | PM3004 |
| 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 |
Device Dimensions
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017159044 [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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