Primary Device ID | M803038055 |
NIH Device Record Key | 5f14f176-669f-4711-ac65-93a46e924550 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lletz Graves Vu-More Speculum Medium Closed Tube |
Version Model Number | Lletz Graves Vu-More Speculum Medium Closed Tube 1 |
Catalog Number | 038055 |
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 | M803038055 [Primary] |
HDF | Speculum, Vaginal, Metal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
Moist Heat or Steam Sterilization
[M803038055]
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 |
M803038030 - Lletz Graves Speculum Small, Closed Tube | 2025-04-28 Lletz Graves Speculum Small, Closed Tube 3/4 inch x 3inch (19mm x 76mm) |
M803038031 - Lletz Graves Speculum Medium, Closed Tube | 2025-04-28 Lletz Graves Speculum Medium, Closed Tube 1 3/8" x 4" (35mm x 102mm) |
M803038032 - Lletz Graves Speculum Large, Closed Tube | 2025-04-28 Lletz Graves Speculum Large, Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm) |
M803038033 - Lletz Graves Speculum Extra Large, Closed Tube | 2025-04-28 Lletz Graves Speculum Extra Large, Closed Tube 1 1/2" x 61/2" (38mm x 165mm) |
M803038040 - Lletz Pederson Speculum Small, Closed Tube | 2025-04-28 Lletz Pederson Speculum Small, Closed Tube 1/2" x 3" (13mm x 76mm) |
M803038041 - Lletz Pederson Speculum Medium, Closed Tube | 2025-04-28 Lletz Pederson Speculum Medium, Closed Tube 7/8" x 4" (22mm x 102mm) |
M803038042 - Lletz Pederson Speculum Large, Closed Tube | 2025-04-28 Lletz Pederson Speculum Large, Closed Tube 1" x 4 3/4" (25mm x 121mm) |
M803038043 - Lletz Pederson Speculum Extra Large, Closed Tube | 2025-04-28 Lletz Pederson Speculum Extra Large, Closed Tube 1" x 6 1/2" (25mm x 165mm) |