| Primary Device ID | 00850017652750 |
| NIH Device Record Key | 840df25b-0116-46ba-9d2b-640cd9a5f829 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZGO C-Guide Sleeve |
| Version Model Number | ZCG |
| Company DUNS | 081472844 |
| Company Name | VERSAH, LLC |
| Device Count | 1 |
| 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 | true |
| 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 | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com | |
| Phone | 844-711-5585 |
| info@versah.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017652750 [Primary] |
| NAP | Cardiac Support Mesh Wrap |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-07 |
| Device Publish Date | 2022-06-29 |
| 00850017652798 - Densah® Bur G3 | 2023-09-27 4.5mm-4.5mm Densah® Bur G3 33mm length |
| 00850017652804 - Densah® Bur G3 | 2023-09-27 4.8mm-5.8mm Densah® Bur G3 33mm length |
| 00850017652811 - Densah® Bur G3 | 2023-09-27 5.5mm-6.5mm Densah® Bur G3 |
| 00850017652828 - Densah® Bur G3 | 2023-09-27 5.5mm-6.8mm Densah® Bur G3 |
| 00850017652606 - 1.5mm-2.5mm ZGO Densah Bur 55mm length | 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid |
| 00850017652613 - 1.5mm-2.5mm ZGO Densah Bur 65mm length | 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid |
| 00850017652620 - 1.5mm-2.5mm ZGO Densah Bur 90mm length | 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid |
| 00850017652637 - 2.0mm-3.0mm ZGO Densah Bur 55mm length | 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid |