| Primary Device ID | 10817583020663 |
| NIH Device Record Key | e2735335-fb14-44da-8650-adf5caecd092 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Critical Cover |
| Version Model Number | BO-13824-B |
| Catalog Number | BO-13824-B |
| Company DUNS | 102710720 |
| Company Name | Alpha Pro Tech, Inc. |
| Device Count | 100 |
| 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 | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0235 |
| xx@xx.xx | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX | |
| Phone | 1-520-281-0127 |
| XX@XX.XX |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817583020666 [Unit of Use] |
| GS1 | 10817583020663 [Primary] |
| GS1 | 20817583020660 [Package] Package: Case [10 Units] In Commercial Distribution |
| FYF | Cap, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2018-07-16 |
| 20817583021452 | Hood, GenPro, Open Face, Elastic Face & Neck, Serged Seam, White 2XL |
| 20817583020745 | Shoe Cover, SureGrip, Conductive for ESD Concerns, Anti-Skid, Serged Seams, Blue, XL. |
| 20817583020738 | Shoe Cover, SureGrip, Conductive for ESD concerns, Anti-Skid, Serged Seams, Blue, Universal. |
| 20817583020721 | Hood, GenPro, Open face, Elastic Face & Neck, Serged Seams, Blue XL. |
| 10817583020717 | Hood, GenPro, Open face, Elastic face & neck, Serged Seams, White, XL |
| 20817583020707 | Beard Cover, GenPro, Lightweight, Serged Seams, White, Universal. |
| 20817583020677 | Bouffant Cap, GenPro, Lightweight, Serged Seams, 26", White |
| 10817583020663 | Bouffant Cap, GenPro, Lightweight, Serged Seams, 24", White |
| 10817583020656 | Bouffant Cap, GenPro, Lightweight, Serged Seams, 21", White |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRITICAL COVER 74543561 1986148 Live/Registered |
Alpha Pro Tech, Inc. 1994-06-29 |