BladeX Blade 202-82038

GUDID 00810097800939

BladeX Blade

SMV SCIENTIFIC LLC

Orthopaedic osteotome blade, single-use
Primary Device ID00810097800939
NIH Device Record Key0c7018a1-1397-40d8-8ad1-518f85b4710c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBladeX Blade
Version Model Number202-82038
Catalog Number202-82038
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
GS100810097800939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GESBlade, Scalpel
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


[00810097800939]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-24
Device Publish Date2022-08-16

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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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