| Primary Device ID | 00855638007019 |
| NIH Device Record Key | 98410c83-1edf-4cb5-9b2d-671f4c61e1fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProLayer Xenograft |
| Version Model Number | 3102-2144 |
| Company DUNS | 801160037 |
| Company Name | STELLEN MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
| Length | 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855638007019 [Primary] |
| FTM | Mesh, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-06 |
| 00855638007033 | Acellular dermal matrix |
| 00855638007026 | Acellular Dermal Matrix |
| 00855638007019 | Acellular Dermal Matrix |
| 00855638007002 | Acellular Dermal Matrix |