Primary Device ID | M803038062 |
NIH Device Record Key | a1777e5f-2bad-4af0-bf04-9975d88f7041 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lletz Lateral Vaginal Wall Retractor Open |
Version Model Number | Vaginal Wall Retractor Open 1" (25mm), Blade 1" x |
Catalog Number | 038062 |
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 | M803038062 [Primary] |
HDF | Speculum, Vaginal, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
Moist Heat or Steam Sterilization
[M803038062]
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) |