| Primary Device ID | M80303064012 |
| NIH Device Record Key | 5a4473a2-b70f-49b6-96cc-715ab08520f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sims Malleable Curette |
| Version Model Number | Sims Malleable Curette 12pc Set Sizes #00-10 |
| Catalog Number | 03064012 |
| 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 | M80303064012 [Primary] |
| KOH | Instrument, Manual, General Obstetric-Gynecologic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M80303064012]
Moist Heat or Steam Sterilization
[M80303064012]
Moist Heat or Steam Sterilization
[M80303064012]
Moist Heat or Steam Sterilization
[M80303064012]
Moist Heat or Steam Sterilization
[M80303064012]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-24 |
| Device Publish Date | 2025-11-16 |
| M803030640 | Sims Malleable Curette 8pc Set Sizes #00 - #6 |
| M803030649 | Sims Malleable Curette #7 |
| M803030648 | Sims Malleable Curette #6 |
| M803030647 | Sims Malleable Curette #5 |
| M803030646 | Sims Malleable Curette #4 |
| M803030645 | Sims Malleable Curette #3 |
| M803030644 | Sims Malleable Curette #2 |
| M803030643 | Sims Malleable Curette #1 |
| M803030642 | Sims Malleable Curette #0 |
| M80303064012 | Sims Malleable Curette 12pc Set Sizes #00-10 |