GELPI SPINAL RETRACTOR 230-365

GUDID 00192896026551

GELPI SPINAL RETRACTOR WITH SPEED LOCK ANGLED CEREBELLAR TIP

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 ID00192896026551
NIH Device Record Key61cd2b6a-505c-4fba-a375-2076180ce168
Commercial Distribution StatusIn Commercial Distribution
Brand NameGELPI SPINAL RETRACTOR
Version Model Number230-365
Catalog Number230-365
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

Device Size Text, specify0
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0
Length13.5 Inch
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896026551 [Primary]

FDA Product Code

FFORETRACTOR, SELF-RETAINING
GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896026551]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-12
Device Publish Date2018-09-11

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