| Primary Device ID | M803030978 |
| NIH Device Record Key | b22bd1e5-136a-4908-a002-9b3f6f4f2c29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Graves Vu-Max X Long |
| Version Model Number | Graves Vu-Max X Long 6 1/3" (161mm) |
| Catalog Number | 030978 |
| Company DUNS | 103913430 |
| Company Name | MEDGYN PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M803030978 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
[M803030978]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-03 |
| Device Publish Date | 2025-05-26 |
| M803030980 | Graves Vu-Max X Long 7" (178mm) |
| M803030979 | Graves Vu-Max X Long 6 3/4" (171mm) |
| M803030978 | Graves Vu-Max X Long 6 1/3" (161mm) |
| M803030977 | Graves Vu-Max X Long 6" (152mm) |