| Primary Device ID | 00192896071964 |
| NIH Device Record Key | 70ae3877-a248-478d-b85f-a5c82ff9cd6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BALFOUR RETRACTOR |
| Version Model Number | 1100-6071-SET |
| Catalog Number | 1100-6071-SET |
| 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 | 10.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896071964 [Primary] |
| FFO | Retractor, Self-Retaining |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896071964]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-05 |
| Device Publish Date | 2018-10-04 |
| 00192896081819 | BALFOUR RETRACTOR LARGE SPREAD |
| 00192896072077 | BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE |
| 00192896072060 | BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE |
| 00192896072053 | BALFOUR RETRACTOR DOUBLE BAR |
| 00192896072046 | BALFOUR RETRACTOR |
| 00192896071988 | BALFOUR RETRACTOR WITH DOUBLE BAR DETACHABLE WIRE BLADES |
| 00192896071964 | BALFOUR RETRACTOR LARGE SIZE |
| 00192896071957 | BALFOUR RETRACTOR WITH DOUBLE BAR |
| 00192896071940 | BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATE SIDE BLADES |
| 00192896097759 | BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATED SIDE BLADES |
| 00192896097773 | BALFOUR RETRACTOR DOUBLE BAR WITH DETACHABLE WIRE BLADES |
| 00192896097766 | BALFOUR RETRACTOR DOUBLE BAR SPREAD |
| 00192896094918 | BALFOUR RETRACTOR DOUBLE BAR WITH BLADES |