Primary Device ID | 00192896071957 |
NIH Device Record Key | de711c8f-4a0f-4594-99e9-b3482ebf2b02 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BALFOUR RETRACTOR |
Version Model Number | 1100-607-SET |
Catalog Number | 1100-607-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 | 9 Inch |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00192896071957 [Primary] |
FFO | Retractor, Self-Retaining |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00192896071957]
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 |