| Primary Device ID | B0995085510 |
| NIH Device Record Key | 0d9c450e-f741-47fb-9fae-bb44fdc8e5fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LATEX O-RINGS |
| Version Model Number | 508-551 |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896044685 [Primary] |
| HIBCC | B0995085510 [Previous] |
| FHN | Ligator, Hemorrhoidal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B0995085510]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B0995085510]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[B0995085510]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2018-09-07 |
| B0995085510 | LATEX O-RINGS REGULAR (100 PER BAG) |
| B0995085520 | LATEX O-RINGS SMALL (100 PER BAG) |