| 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 |
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