| Primary Device ID | 00192896081079 | 
| NIH Device Record Key | 05f9a64d-9501-45d3-bf38-13e5040b5fe3 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | HEGAR DILATOR | 
| Version Model Number | 520-556 | 
| Catalog Number | 520-556 | 
| 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 | 00192896081079 [Primary] | 
| HDQ | DILATOR, CERVICAL, FIXED SIZE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896081079]
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 |