Black Diamond POCT 2420-0080

GUDID B06224200080

3.5x80mm Rod, Curved, Black Diamond POCT

Osseus Fusion Systems, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB06224200080
NIH Device Record Keyba8ec4d3-d780-4bf4-8124-ffb28a8754d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlack Diamond POCT
Version Model Number2420-0080
Catalog Number2420-0080
Company DUNS933442068
Company NameOsseus Fusion Systems, 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB06224200080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


[B06224200080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [Black Diamond POCT]

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B062242045364.5x36mm Screw, Drilling, Black Diamond POCT
B062242045344.5x34mm Screw, Drilling, Black Diamond POCT
B062242045324.5x32mm Screw, Drilling, Black Diamond POCT
B062242045304.5x30mm Screw, Drilling, Black Diamond POCT
B062242045284.5x28mm Screw, Drilling, Black Diamond POCT
B062242045264.5x26mm Screw, Drilling, Black Diamond POCT
B062242045244.5x24mm Screw, Drilling, Black Diamond POCT
B062242035223.5x22mm Screw, Drilling, Black Diamond POCT
B062242035203.5x20mm Screw, Drilling, Black Diamond POCT
B062242035183.5x18mm Screw, Drilling, Black Diamond POCT
B062242035163.5x16mm Screw, Drilling, Black Diamond POCT
B062242035143.5x14mm Screw, Drilling, Black Diamond POCT
B062242035123.5x12mm Screw, Drilling, Black Diamond POCT
B062242035103.5x10mm Screw, Drilling, Black Diamond POCT
B062242035093.5x08mm Screw, Tapping, Black Diamond POCT
B062242001603.5x160mm Rod, Curved, Black Diamond POCT
B062242001503.5x150mm Rod, Curved, Black Diamond POCT
B062242001403.5x140mm Rod, Curved, Black Diamond POCT
B062242001303.5x130mm Rod, Curved, Black Diamond POCT
B062242001203.5x120mm Rod, Curved, Black Diamond POCT
B062242001153.5x115mm Rod, Curved, Black Diamond POCT
B062242001103.5x110mm Rod, Curved, Black Diamond POCT
B062242001053.5x105mm Rod, Curved, Black Diamond POCT
B062242001003.5x100mm Rod, Curved, Black Diamond POCT
B062242000953.5x95mm Rod, Curved, Black Diamond POCT
B062242000903.5x90mm Rod, Curved, Black Diamond POCT
B062242000853.5x85mm Rod, Curved, Black Diamond POCT
B062242000803.5x80mm Rod, Curved, Black Diamond POCT
B062242000753.5x75mm Rod, Curved, Black Diamond POCT
B062242000703.5x70mm Rod, Curved, Black Diamond POCT
B062242000653.5x65mm Rod, Curved, Black Diamond POCT
B062242000603.5x60mm Rod, Curved, Black Diamond POCT
B062242000553.5x55mm Rod, Curved, Black Diamond POCT
B062242000503.5x50mm Rod, Curved, Black Diamond POCT
B062242000453.5x45mm Rod, Curved, Black Diamond POCT
B062242000403.5x40mm Rod, Curved, Black Diamond POCT
B062242000353.5x35mm Rod, Curved, Black Diamond POCT
B062242000303.5x30mm Rod, Curved, Black Diamond POCT
B062242000253.5x25mm Rod, Curved, Black Diamond POCT
B06224200002Locking Cap Nut, HH Connector, Black Diamond POCT
B06224200001Locking Cap, HH Connector, Black Diamond POCT
B06224200000Locking Cap, Black Diamond POCT

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