| Primary Device ID | B046BIO110430 |
| NIH Device Record Key | fad0077b-28e7-4245-9aa7-55711c16e47e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alligator Rongeur |
| Version Model Number | 9" |
| Catalog Number | BIO-1-1043 |
| Company DUNS | 169289308 |
| Company Name | SIGNAL MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046BIO110430 [Primary] |
| HTX | Rongeur |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B046BIO110430]
Moist Heat or Steam Sterilization
[B046BIO110430]
Moist Heat or Steam Sterilization
[B046BIO110430]
Moist Heat or Steam Sterilization
[B046BIO110430]
Moist Heat or Steam Sterilization
[B046BIO110430]
Moist Heat or Steam Sterilization
[B046BIO110430]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-20 |
| Device Publish Date | 2022-05-12 |
| B046BIO110420 | 7" Alligator Rongeur |
| B046BIO110410 | 5" Alligator Rongeur |
| B046BIO110430 | 9" Alligator Rongeur |