Primary Device ID | M803038129 |
NIH Device Record Key | c93b95c9-2d2f-4b45-8e9f-a7f7b4c0253c |
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 6 1/3" (1 |
Catalog Number | 038129 |
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 | M803038129 [Primary] |
HDF | Speculum, Vaginal, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
Moist Heat or Steam Sterilization
[M803038129]
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) |