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 |