3.2mm Guide Wire 330mm 202-80200

GUDID 00810097800953

3.2mm Guide Wire 330mm

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device ID00810097800953
NIH Device Record Keycfa43862-1bb0-4714-aa8f-8011496689ae
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.2mm Guide Wire 330mm
Version Model Number202-80200
Catalog Number202-80200
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 Dimensions

Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter
Outer Diameter3.2 Millimeter
Length330 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097800953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

Moist Heat or Steam Sterilization


[00810097800953]

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.