Graft Inserter Funnel 202-0301

GUDID 00810097801103

Graft Inserter Funnel

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device ID00810097801103
NIH Device Record Key5efe7b61-c941-44b2-8a35-b77e2cb0fa8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGraft Inserter Funnel
Version Model Number202-0301
Catalog Number202-0301
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
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 Usetrue
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

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097801103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


[00810097801103]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-24
Device Publish Date2022-08-16

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.