| Primary Device ID | M803030941 |
| NIH Device Record Key | be941daa-bc96-4000-9df3-dbb5f63b8942 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pederson XNarrow |
| Version Model Number | Pederson XNarrow 5/8" x 4" (17mm x 102mm) |
| Catalog Number | 030941 |
| 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 | M803030941 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
[M803030941]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-03 |
| Device Publish Date | 2025-05-26 |
| M803030942 | Pederson XNarrow - Right Side Open 5/8" x 4" (17mm x 102mm) |
| M803030941 | Pederson XNarrow 5/8" x 4" (17mm x 102mm) |