| Primary Device ID | M803038131 |
| NIH Device Record Key | 56060aab-4fa8-4a02-8721-ccd76dd9faa5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lletz Graves Vu-Max Speculum Extra Large |
| Version Model Number | Lletz Graves Vu-Max Speculum Extra Large 7" (178mm |
| Catalog Number | 038131 |
| 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 | M803038131 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
[M803038131]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-28 |
| Device Publish Date | 2025-04-19 |
| M803038131 | Lletz Graves Vu-Max Speculum Extra Large 7" (178mm) |
| M803038130 | Lletz Graves Vu-Max Speculum Extra Large 6 2/3" (169mm) |
| M803038129 | Lletz Graves Vu-Max Speculum Extra Large 6 1/3" (161mm) |
| M803038128 | Lletz Graves Vu-Max Speculum Extra Large 5 7/8" (149mm) |