12 x 70mm Anodized SI Implant 1252-1012-070

GUDID 00810097800045

12 x 70mm Anodized SI Implant

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810097800045
NIH Device Record Keye84a0fba-69fa-41d2-81d5-cd5b18faf8c1
Commercial Distribution StatusIn Commercial Distribution
Brand Name12 x 70mm Anodized SI Implant
Version Model Number1252-1012-070
Catalog Number1252-1012-070
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Dimensions

Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter
Outer Diameter12 Millimeter
Length70 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097800045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


[00810097800045]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-25
Device Publish Date2022-02-17

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00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
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