| Primary Device ID | M803040060 |
| NIH Device Record Key | aae5e3d5-e3f5-4f67-987f-2b4519a9afa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Repaired Products |
| Version Model Number | Repaired Products |
| Catalog Number | 040060 |
| 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 | M803040060 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
[M803040060]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-31 |
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| M803029803 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Left |
| M803029804 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Right |
| M803029811 - Baby Tischler Biopsy Punch | 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Up |
| M803029812 - Baby Tischler Biopsy Punch | 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Down |