GELPI SPINAL RETRACTOR 230-405

GUDID 00192896026643

GELPI SPINAL RETRACTOR DEEP ANGLED MULTILEVEL DISTRACTION PARALLEL TIPS

SONTEC INSTRUMENTS, INC.

Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable Self-retaining surgical retractor, reusable
Primary Device ID00192896026643
NIH Device Record Keyd7ef07f7-81da-46f2-922c-05db49b74503
Commercial Distribution StatusIn Commercial Distribution
Brand NameGELPI SPINAL RETRACTOR
Version Model Number230-405
Catalog Number230-405
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
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896026643 [Primary]

FDA Product Code

FFORETRACTOR, SELF-RETAINING
GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896026643]

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 Date2018-09-14

On-Brand Devices [GELPI SPINAL RETRACTOR]

00192896048935GELPI RETRACTOR MICRO PARALLEL BLUNT BLADES
00192896038042GELPI SPINAL RETRACTOR WITH RATCHET DEEP ANGLED DOUBLE TIPS
00192896026643GELPI SPINAL RETRACTOR DEEP ANGLED MULTILEVEL DISTRACTION PARALLEL TIPS
00192896026605GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP
00192896026599GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP
00192896026582GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP
00192896026575GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP
00192896026568GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED TIP
00192896026551GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED CEREBELLAR TIP
00192896117341Gelpi Spinal Retractor Deep Angle Blunt Tips With Speed Lock 90 Degrees

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