| Primary Device ID | 00858150000520 |
| NIH Device Record Key | 0d67f757-98dd-4724-be40-0bbd2d800375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NTERFACE |
| Version Model Number | 3810-288 |
| Catalog Number | 3810-288 |
| Company DUNS | 050087089 |
| Company Name | WINFIELD LABORATORIES INC |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com | |
| Phone | 801-352-0600 |
| chrisd@winfieldlabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858150000490 [Primary] |
| GS1 | 00858150000520 [Unit of Use] |
| GS1 | 10858150000497 [Package] Contains: 00858150000490 Package: Case [48 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
[00858150000520]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-22 |
| Device Publish Date | 2020-07-14 |
| 00858150000551 | Roll 4 inches X 10 inches - Box 6 |
| 00858150000520 | Large Sheet 12 inches X 24 inches - Box 12 |
| 00858150000544 | Single Sheet 12 inches X 12 inches - Box 12 |
| 00858150000537 | Strip 4 inches X 12 inches - Box 12 |
| 00858150000469 | Square 4 inches X 4 inches - Box 25 |