5.5 x 65mm CURVED ROD 101-10065

GUDID 00810097802568

5.5 x 65mm CURVED ROD

SMV SCIENTIFIC LLC

Orthopaedic instrument surgical connector
Primary Device ID00810097802568
NIH Device Record Key4c90a86d-4263-4d90-a6bd-19d42b7980c5
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.5 x 65mm CURVED ROD
Version Model Number101-10065
Catalog Number101-10065
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

Device Dimensions

Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter
Outer Diameter5.5 Millimeter
Length65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097802568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


[00810097802568]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-25
Device Publish Date2023-04-17

Devices Manufactured by SMV SCIENTIFIC LLC

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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

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