| Primary Device ID | M803038061 |
| NIH Device Record Key | bd7ca8c8-3c0c-4ec2-beff-1d595161f703 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lletz Lateral Vaginal Wall Retractor Open |
| Version Model Number | Vaginal Wall Retractor Open 1/2" (13mm), Blade 1" |
| Catalog Number | 038061 |
| 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 | M803038061 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
Moist Heat or Steam Sterilization
[M803038061]
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 |
| M803038062 | Vaginal Wall Retractor Open 1" (25mm), Blade 1" x 2 1/2" (25mm x 64mm) |
| M803038061 | Lletz Lateral Vaginal Wall Retractor Open 1/2" (13mm), Blade 1" x 2 1/2" (25mm x 64mm) |