4.0 x 16mm Screw Super Fastener, ST 340-2016

GUDID 00810074300025

4.0 x 16mm Screw Super Fastener, ST

SMV SCIENTIFIC LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00810074300025
NIH Device Record Key528d493f-a9ca-41c4-8539-9f318436b6f3
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0 x 16mm Screw Super Fastener, ST
Version Model Number340-2016
Catalog Number340-2016
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

Device Dimensions

Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter
Outer Diameter4 Millimeter
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810074300025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


[00810074300025]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

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, ST2023-06-204.0 x 16mm 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

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