| Primary Device ID | 00192896081048 |
| NIH Device Record Key | 56c190c7-5c0c-4019-ad5e-0d836016b202 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEGAR DILATOR |
| Version Model Number | 520-551 |
| Catalog Number | 520-551 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Length | 7.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896081048 [Primary] |
| HDQ | DILATOR, CERVICAL, FIXED SIZE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896081048]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-09-20 |
| 00192896081079 | HEGAR DILATOR DOUBLE ENDED TIP SIZES 13-14 |
| 00192896081062 | HEGAR DILATOR DOUBLE ENDED TIP SIZES 11-12 |
| 00192896081055 | HEGAR DILATOR DOUBLE ENDED TIP SIZES 9-10 |
| 00192896081048 | HEGAR DILATOR DOUBLE ENDED TIP SIZES 3-4 |
| 00192896106345 | Hegar Dilator Double End Sizes 15-16 |