| Primary Device ID | B0995085500 |
| NIH Device Record Key | e8312411-426d-4410-9ced-551ee9270aa5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MCGIVNEY HEMORRHOIDAL LIGATOR |
| Version Model Number | 508-550 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| 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 | true |
| 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 | 800-821-7496 |
| info@sontecinstruments.com | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com | |
| Phone | 800-821-7496 |
| info@sontecinstruments.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896044678 [Primary] |
| HIBCC | B0995085500 [Previous] |
| FHN | Ligator, Hemorrhoidal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B0995085500]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B0995085500]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[B0995085500]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2018-09-06 |
| 00192896121621 - Gelpi Retractor | 2025-06-25 Gelpi Retractor Deep Angle With Enclosed Ratchet 6.5 Inches |
| 00192896121638 - Debakey Neonatal Clamp | 2025-06-25 Debakey Neonatal Clamp Medium Full Curved Jaw/Shank A |
| 00192896121645 - Debakey Neonatal Clamp | 2025-06-25 Debakey Neonatal Clamp Double Angled 45 Degrees Jaw/Shank A |
| 00192896121652 - Debakey Scissors | 2025-06-25 Debakey Scissors 45 Degree Angle Power Cut |
| 00192896121362 - Barraquer Iris Spatula | 2025-06-16 Barraquer Iris Spatula Round Smooth Curved Blades |
| 00192896121607 - Micasept Top Dur Needle Holder | 2025-06-16 Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip |
| 00192896121614 - Circular Cutting Punch | 2025-06-16 Circular Cutting Punch 70 Degree Upturned With Flushing Connector |
| 00192896121577 - Stefan Mini Bone Holding Forceps | 2025-06-02 Stefan Mini Bone Holding Forceps With Speed Lock Serrated Jaw Curved Delicate Quantum |