| Primary Device ID | 10801741010559 |
| NIH Device Record Key | 56f2b37b-010c-45b8-be77-0332398f93f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avitene Ultrafoam |
| Version Model Number | 1050050 |
| Catalog Number | 1050050 |
| Company DUNS | 001191048 |
| Company Name | Davol 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 | 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 |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com | |
| Phone | +1(800)562-0027 |
| medical.services@crbard.com |
| Depth | 3 Millimeter |
| Depth | 3 Millimeter |
| Depth | 3 Millimeter |
| Depth | 3 Millimeter |
| Depth | 3 Millimeter |
| Depth | 3 Millimeter |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741010552 [Primary] |
| GS1 | 10801741010559 [Package] Contains: 00801741010552 Package: CA [6 Units] In Commercial Distribution |
| LMF | Agent, absorbable hemostatic, collagen based |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-12 |
| 10801741010559 | Avitene Ultrafoam Collagen Hemostat |
| 10801741010542 | Avitene Ultrafoam Collagen Hemostat |
| 10801741010535 | Avitene Ultrafoam Collagen Hemostat |
| 10801741010528 | Avitene Ultrafoam Collagen Hemostat |