| Primary Device ID | 00615375001721 |
| NIH Device Record Key | f5824f15-034a-4f51-90f5-1948590c1bd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoraGard |
| Version Model Number | 29520DX |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 50 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com | |
| Phone | +18005377123 |
| customercare@kavokerrgroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00615375001721 [Primary] |
| GS1 | 00615375008409 [Unit of Use] |
| BRW | PROTECTOR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-31 |
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