3.5mm Drill Bit X 125mm, OsteoGuard 110029

GUDID 00816950029318

3.5mm Drill Bit X 125mm, OsteoGuard

SMV SCIENTIFIC LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00816950029318
NIH Device Record Key50ba91b9-7888-4480-9387-26faa2f3e014
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm Drill Bit X 125mm, OsteoGuard
Version Model Number110029
Catalog Number110029
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

Device Dimensions

Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter
Outer Diameter3.5 Millimeter
Length125 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

[00816950029318]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

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