BALFOUR RETRACTOR 1100-6071-SET

GUDID 00192896071964

BALFOUR RETRACTOR LARGE SIZE

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable
Primary Device ID00192896071964
NIH Device Record Key70ae3877-a248-478d-b85f-a5c82ff9cd6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBALFOUR RETRACTOR
Version Model Number1100-6071-SET
Catalog Number1100-6071-SET
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length10.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896071964 [Primary]

FDA Product Code

FFORetractor, Self-Retaining

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896071964]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-05
Device Publish Date2018-10-04

On-Brand Devices [BALFOUR RETRACTOR]

00192896081819BALFOUR RETRACTOR LARGE SPREAD
00192896072077BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
00192896072060BALFOUR RETRACTOR DOUBLE BAR FENESTRATED SIDE BLADE
00192896072053BALFOUR RETRACTOR DOUBLE BAR
00192896072046BALFOUR RETRACTOR
00192896071988BALFOUR RETRACTOR WITH DOUBLE BAR DETACHABLE WIRE BLADES
00192896071964BALFOUR RETRACTOR LARGE SIZE
00192896071957BALFOUR RETRACTOR WITH DOUBLE BAR
00192896071940BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATE SIDE BLADES
00192896097759BALFOUR RETRACTOR WITH DOUBLE BAR FENESTRATED SIDE BLADES
00192896097773BALFOUR RETRACTOR DOUBLE BAR WITH DETACHABLE WIRE BLADES
00192896097766BALFOUR RETRACTOR DOUBLE BAR SPREAD
00192896094918BALFOUR RETRACTOR DOUBLE BAR WITH BLADES

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.