LUMBAR/CERVICAL IMPACTOR 335-390

GUDID 00192896031333

LUMBAR/CERVICAL IMPACTOR

SONTEC INSTRUMENTS, INC.

Orthopaedic implant impactor
Primary Device ID00192896031333
NIH Device Record Keyc9e158da-e21b-4e40-bb45-cb5aeb39f762
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUMBAR/CERVICAL IMPACTOR
Version Model Number335-390
Catalog Number335-390
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

Length8.5 Inch
Length8.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896031333 [Primary]

FDA Product Code

HWAIMPACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896031333]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-12

On-Brand Devices [LUMBAR/CERVICAL IMPACTOR]

00192896031401LUMBAR/CERVICAL IMPACTOR WIDE LATERAL
00192896031395LUMBAR/CERVICAL IMPACTOR WIDE LATERAL
00192896031388LUMBAR/CERVICAL IMPACTOR GUARDED MICROSCOPIC LATERAL
00192896031371LUMBAR/CERVICAL IMPACTOR MICROSCOPIC LATERAL OFFSET
00192896031364LUMBAR/CERVICAL IMPACTOR MICRO LATERAL OFFSET WITH HEEL
00192896031357LUMBAR/CERVICAL IMPACTOR MICRO LATERAL OFFSET WITHOUT HEEL
00192896031340LUMBAR/CERVICAL IMPACTOR LATERAL NARROW TIPS
00192896031333LUMBAR/CERVICAL IMPACTOR

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