| Primary Device ID | M803020301 |
| NIH Device Record Key | 79e010ea-28e4-4eb6-8d80-def739caf821 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedGyn Disposable Amnio Hook |
| Version Model Number | Amniotome |
| Catalog Number | 020301 |
| Company DUNS | 103913430 |
| Company Name | MEDGYN PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | M803020301 [Primary] |
| HGE | Amniotome |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| M8030030976 - Graves Vu-Max Large | 2025-06-03 Graves Vu-Max Large 5" (127mm) |
| M803030906 - Pederson Small | 2025-06-03 Pederson Small 1/2" x 3" (13mm x 76mm) |
| M803030907 - Pederson Medium | 2025-06-03 Pederson Medium 7/8" x 4" (22mm x 102mm) |
| M803030908 - Pederson Large | 2025-06-03 Pederson Large 1" x 4 3/4" (25mm x 121mm) |
| M803030910 - Graves Wide Angled Medium Right Side Open | 2025-06-03 Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm) |
| M803030911 - Weisman Graves Medium - Right Side Open | 2025-06-03 Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm) |
| M803030912 - Weisman Graves Medium | 2025-06-03 Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm) |
| M803030913 - Pederson XSmall | 2025-06-03 Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm) |