SPINAL DISTRACTOR 416-605

GUDID 00192896037595

SPINAL DISTRACTOR ANGLED LARGE

SONTEC INSTRUMENTS, INC.

Orthopaedic surgical distractor, internal
Primary Device ID00192896037595
NIH Device Record Key4d3e71a0-2e5f-4034-862c-f295438d5c4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINAL DISTRACTOR
Version Model Number416-605
Catalog Number416-605
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896037595 [Primary]

FDA Product Code

HWNINSTRUMENT, COMPRESSION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896037595]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-11
Device Publish Date2018-09-10

On-Brand Devices [SPINAL DISTRACTOR]

00192896037595SPINAL DISTRACTOR ANGLED LARGE
00192896037588SPINAL DISTRACTOR
00192896095403SPINAL DISTRACTOR ANGLED

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