BladeX Blade Sterile 202-82038-S

GUDID 00810097801196

BladeX Blade Sterile

SMV SCIENTIFIC LLC

Orthopaedic osteotome blade, single-use
Primary Device ID00810097801196
NIH Device Record Key1e22b9d0-7b82-4057-bb3c-eb31c320ab1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBladeX Blade Sterile
Version Model Number202-82038-S
Catalog Number202-82038-S
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

Device Dimensions

Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter
Length38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097801196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GESBlade, Scalpel
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-25
Device Publish Date2022-08-17

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